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BRS | The Brief Resilience Scale [ | PMC10426081 |
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Procedure | PMC10426081 |
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PoET | Figure Chronological order of PoET procedure | PMC10426081 |
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Control | Participants of the control group only filled out the questionnaires at three assessment points. This happened in the same intervals as in the PoET group. They received the link to the questionnaires via email.This study was approved by the Local Ethics Committee for Psychological Studies of Ruhr-University Bochum. All methods were performed in accordance with the relevant guidelines and regulations. | PMC10426081 |
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Data analysis | The statistics program R Studio (version 2022.02.3) [In addition, we examined whether the individual constructs that were treated as lessons during the training had changed in the PoET group in comparison to the control group by conducting another two-factor analysis of variance with repeated measures. The two groups served as between-subject factor and the three assessment points as within-subject factor (2 × 3 mixed design).The level of significance was set as | PMC10426081 |
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Results | PMC10426081 |
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Results at baseline | At T1, the two groups significantly differed from each other in their PMH scores (
Baseline results for PMH and DASS-21 scores in PoET and control group
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Effects of PoET on PMH scores | Descriptively, there was a higher increase in the PoET group PMH sum scores from T1 to T2 and T1 to T3 compared to the control group. While the PMH scores of the control group were significantly higher at T1, the PoET PMH scores approached the control at T2 and T3. The repeated measures ANOVA also showed a significant
Mean differences between assessment points (PMH)T1 – T2T1 – T3T2 – T31.931.78-0.150.1930.2611T1 – T2T1 – T3T2 – T30.310.370.06111
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Effects of PoET on DASS-21 scores | depression, anxiety | POSITIVE | The repeated measures ANOVA showed significant For the DASS-S there was a significant Changes in different measures for all assessment points and groups. Note. The blue lines depict significant changes in the PoET group. Significant differences between the groups at one specific assessment point are presented in black. PMH = Positive Mental Health Scale, DASS-21 = Depression-Anxiety-Stress Scale, DASS-D = Subscale “depression”, DASS-A = Subscale “anxiety”, DASS-S = Subscale “stress”, LOT-r = Life Orientation Test revised, GQ-5 = Gratitude Questionnaire, BRS = Brief Resilience Scale, SWLS = Satisfaction with Life Scale, NGSE = New General Self-Efficacy Scale. * | PMC10426081 |
Effects of PoET on discussed positive psychology constructs | PMC10426081 |
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Optimism | The two-factor analysis showed a significant | PMC10426081 |
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Gratitude | With respect to the graphic presentation of descriptive statistics, there was a high increase of mean gratitude scores in the PoET group from T1 to T2 and T1 to T3. Results of the conducted repeated measures ANOVA showed a significant | PMC10426081 |
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Resilience | Descriptive measures showed an increase of mean resilience scores in the PoET group from T1 to T2 and from T2 to T3. In the control group there was a slight decrease of mean resilience scores from T2 to T3. The repeated measures ANOVA showed no significant effects in neither of the two groups nor three assessments (all | PMC10426081 |
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Happiness | While the happiness sum scores in the control group graphically were relatively stable, there was a visible increase in the PoET group from T1 to T2. The repeated measures ANOVA showed a significant | PMC10426081 |
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Self-efficacy | The repeated measures ANOVA showed a significant A graphic presentation of the descriptive data for all relevant measures can be found in Fig.
Mean scores of LOT-r, GQ-5, BRS, SWLS and NGSE
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Discussion | depression, anxiety | The main goal of this study was to evaluate the practicability of PoET and to examine whether PoET might be effective to promote mental health in the general population. We hypothesized an increase in positive mental health factors (Hypothesis 1) and a decrease in depression, anxiety, and stress symptoms (Hypothesis 2) in PoET participants one month after the second training day. For the control group, we hypothesized that there would be no changes in these scores (Hypothesis 3).Regarding the effectiveness of PoET, our results were mixed but definitely promising. Due to the fact that the groups were not randomly allocated, these findings should be handled with care.According to the first hypothesis, there was a descriptive increase in positive mental health factors assessed with the PMH in the PoET group, but the differences were not significant in the statistical analyses so that the hypothesis could not be confirmed with the present data. These results are in contrast to previous research: While we found no significant changes in PMH scores of the PoET group, other studies showed positive effects of positive psychology interventions on (psychological) well-being [In this regard, it is important to refer to possible reasons for the absence of significance: One of them could be the differences of the PoET and control group. Since the groups were not randomly assigned, they differed significantly in age (The second hypothesis could be partially confirmed with significant decreases of depression and anxiety symptoms assessed with the DASS-21 from T1 to T3. According to Cohen [Overall, these results indicate that PoET is effective to reduce symptoms of depression and anxiety in the general population. It is still to explore, whether an adjusted version of PoET might have similar effects in a clinical population. In the future, based on these promising results, PoET should be further examined and evaluated in a randomized controlled trial.According to the third hypothesis, there were no significant changes in the control group in neither of these measures, which suggests that the improvements in the PoET group can be attributed to the training itself and not to other possible environmental factors.In addition to the three hypotheses, we also examined possible increases in other relevant dimensions in the PoET group in comparison to the control. These were optimism, gratitude, resilience, happiness, and self-efficacy. Solid significant changes could only be found in optimism with a medium effect size [For the other constructs (gratitude, resilience, happiness, and self-efficacy), no significant effects were found, but all of them increased descriptively, indicating that there were slight improvements. Since other studies have shown that positive psychology interventions are able to enhance these constructs [Besides these promising results, the main goal of this study was to test PoET’s feasibility regarding the general concept and the training circumstances. Implementing PoET as a two-session online training was experienced to be feasible by the research team as well as participants. Beforehand, we had considered whether to conduct the training within one session, two sessions or more. Although past positive psychology intervention studies often used five or more training sessions [ | PMC10426081 |
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Limitations and future research | depression, mental illness, depressive, anxiety | When interpreting the results, the following limitations must be considered. There were differences between both groups, that affected their comparability: At T1, the control group scored descriptively lower on the subscales of the DASS-21 and significantly higher (Since the interest in participating in our study was tremendously high (nearly 600 people contacted us), future studies should address the urgent need for low-threshold interventions. Due to its simple structure, our PoET has the potential to build a foundation for a large-scale implementation. Future research is needed to test the effects of PoET on mental health in a randomized controlled trial. This would lead to more comparable groups when assessing the impact of the training on various positive psychological variables. As this research showed that PoET could significantly reduce depression and anxiety scores on the DASS-21 in the general population, it would also be interesting to investigate whether implementing the training can also improve depressive or anxiety symptoms in people with a diagnosed mental illness. Another interesting approach would be a comparison between an online and offline form of PoET to assess possible differences in the effectiveness. | PMC10426081 |
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Conclusion | depression, anxiety | The main goal of the present study was to test the feasibility of a low-threshold intervention promoting positive emotions. The results showed that PoET in its recent form could be successfully conducted in the general population. In addition, significant effects on depression, anxiety, and optimism were found. Overall, PoET appears to have the potential to contribute to psychotherapeutic interventions. After further and clinical validation, PoET as a low-threshold treatment could be used in the area of prevention as well as during the long waiting periods before the beginning of therapy. | PMC10426081 |
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Acknowledgements | We want to thank Helen Copeland-Vollrath for proofreading the manuscript. We also want to thank Inga Schecker, Lara Steinfeldt, Lucia Ueckert and Lisa Weiß for being part of the data collection. We acknowledge support by the Open Access Publication Funds of the Ruhr-Universität Bochum. | PMC10426081 |
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Authors' contributions | “LN and CvG: designed and executed the study, conducted the data analyses, and wrote the paper. XCZ: collaborated in the analyses of the data and edited part of the results. JM: collaborated in the editing of the final manuscript. CT: designed the study, collaborated in the writing and editing of the manuscript. All authors approved the final version of the manuscript for submission.“ | PMC10426081 |
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Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10426081 |
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Availability of data and materials | The datasets used and analyzed during the current study are available from the corresponding author on request. | PMC10426081 |
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Declarations | PMC10426081 |
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Ethics approval and consent to participate | After being informed about the procedure of the study, all participants gave written informed consent. This study was approved by the Local Ethics Committee for Psychological Studies of Ruhr-University Bochum. All methods were performed in accordance with the relevant guidelines and regulations. | PMC10426081 |
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Consent for publication | Not applicable. | PMC10426081 |
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Competing interests | The authors declare that they have no competing interests. | PMC10426081 |
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References | PMC10426081 |
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Abstract | PMC10107788 |
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Objective | uterine artery embolization | To determine treatment options (myomectomy vs. uterine artery embolization (UAE)) for women wishing to avoid hysterectomy. | PMC10107788 |
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Methods | A multicenter randomized controlled trial was conducted on 254 women and data were collected on fibroid‐specific quality of life (UFS‐QOL), loss of menstrual blood, and pregnancy. | PMC10107788 |
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Results | At 4 years, the mean difference in the UFS‐QOL was 5.0 points (95% confidence interval (CI) −1.4 to 11.5; | PMC10107788 |
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Conclusion | bleeding, Leiomyoma | BLEEDING, LEIOMYOMA, UTERINE FIBROIDS | Leiomyoma are common in reproductive‐aged women, causing heavy menses and subfertility. Among women with uterine fibroids, myomectomy resulted in better fibroid‐related quality of life at 4 years, compared with UAE but the treatments decreased menstrual bleeding equally. There was also no significant difference in the impact of treatment on ovarian reserve. | PMC10107788 |
Synopsis | blood loss, uterine fibroids | BLOOD LOSS, UTERINE FIBROIDS | Women with uterine fibroids were randomized between uterine artery embolization and myomectomy. Quality of life was greater in the myomectomy group at 2 years, but neither menstrual blood loss nor markers of ovarian function differed.
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INTRODUCTION | tumor, uterine rupture, fibroid, Uterine artery embolization, Uterine fibroids, temporary occlusion of the arteries, fibroids, infarction | TUMOR, UTERINE RUPTURE, FIBROID, HEAVY MENSTRUAL BLEEDING, FIBROIDS, UTERINE FIBROIDS, UTERINE FIBROIDS, FIBROIDS, UTERUS, INFARCTION | Uterine fibroids are the most common tumor in women of reproductive age, with increasing prevalence as women get older. It is estimated that by the time they are in their 50s, around 80% of women will have developed a fibroid.Recently, childbirth trends have shifted, and more women appear to delay starting their families until their third or fourth decade.The symptoms experienced by women with fibroids may vary depending on the position, size, and number of fibroids. Intramural fibroids are the most common form of fibroid but are frequently asymptomatic. Fibroids can become very large and are often associated with heavy menstrual bleeding. Some clinicians believe that the presence of fibroids may have a negative impact on fertilityThere is still uncertainty as to which is the best treatment for a woman with symptomatic fibroids who wishes to preserve her uterus. To address this, existing and new treatments should be fully evaluated from all perspectives, including the relief of symptoms and the impact on the woman's quality of life, and the data should be subject to careful review.Uterine artery embolization (UAE) involves the temporary occlusion of the arteries supplying the uterus using biocompatible particles and is usually performed under local anesthetic. It causes ischemic infarction from which the uterus usually recovers but the fibroids do not. The use of UAE in women who may wish to conceive is controversial within some sections of the medical community.Both myomectomy and UAE appear to improve the quality of life of women with symptomatic uterine fibroids, but data from high‐quality studies are sparse. For the control of symptoms, the choice is currently unclear and indications and clinical preferences for either modality are varied. Perhaps as a result of the uncertainty of the effect of UAE on fertility, previous randomized controlled trials (RCTs) have not generally included women wishing to get pregnant. This meant that the studies undertaken are poorly designed and inconclusive. One small study reported that the women in the myomectomy arm became pregnant sooner postoperatively than the women in the UAE arm, and live birth rates were significantly lower among the UAE group (relative risk (RR) 2.32, 95% confidence interval (CI) 1.19–4.53; UAE has been performed in Africa and Asia, with reports of success even with large fibroids, as are common in Africa.Myomectomy is also undertaken, but the literature reports a reluctance due to fear of uterine rupture in this and future pregnancies.When compared with the open route, the safety and efficacy of laparoscopic myomectomyPapers discussing UAE are often not in the gynecological literature, which is perhaps not surprising as UAE is undertaken by an interventional radiologist, and many gynecologists around the world are protective of their practice and prefer to manage women from diagnosis to recovery.The aim of the present multicenter open RCT was to assess the clinical effectiveness of these two uterine‐saving fibroid treatments. | PMC10107788 |
MATERIALS AND METHODS | adenomyosis, malignancy, fibroids, loss of menstrual blood | FIBROID, PELVIC INFLAMMATORY DISEASE, ADVERSE EVENTS, BLEEDING, INTRAOPERATIVE COMPLICATION, UTERINE FIBROID, ADENOMYOSIS, FIBROIDS, REGRESSION, BLOOD, COMPLICATIONS | The present study is an open, randomized, parallel multicenter trial comparing two uterine‐saving fibroid treatments with ethics approval from the Coventry and Warwickshire National Research Ethics Service Committee (Reference: 11/WM/0149). It was approved by the UK National Research Ethics Service and the research department at each participating hospital.The participants were recruited from 29 participating hospitals across the UK. Following a full clinical assessment and imaging to confirm the presence of fibroids, the patients were invited to the study if the assessing clinician felt the patient would benefit from either myomectomy or UAE. A trial‐approved member of the local team would then approach the patient at a later date and provide written information on the study. Patients who consented to take part were given a baseline questionnaire. The majority of the participants had magnetic resonance imaging (MRI) scans to map the fibroids. Patients were randomized if they met all the inclusion criteria and none of the exclusion criteria.The inclusion criteria were as follows: women with symptomatic fibroids who did not wish to have a hysterectomy, but who were prepared to accept one in an emergency; women suitable for, and accepting of, either myomectomy or UAE; women for whom the clinical team were uncertain as to which treatment was indicated; and women who provided written informed consent.The exclusion criteria were as follows: women who refused a hysterectomy, even if an intraoperative complication made this an advisable procedure; women with recent or ongoing pelvic inflammatory disease; women with significant adenomyosis, as identified by transvaginal ultrasound or MRI (women with concurrent adenomyosis were eligible if fibroids were believed to be the predominant cause of their symptoms); women with a positive pregnancy test just before consent; postmenopausal women, defined as more than 1 year since the last menstrual period; women with suspected malignancy; women aged under 18 years; women who were unable to provide informed consent because of incapacity (as defined by the Mental Capacity Act 200555 or the Adults with Incapacity (Scotland) Act 200056); non‐English‐speaking women for whom translation or interpretation facilities were insufficient to guarantee informed consent; and women who had previously undergone myomectomy via a laparotomy or had previously undergone embolization.A sample size of 250 participants was estimated to have a power of 90% (at a two‐sided alpha level of 0.05) to detect a moderate‐sized difference between the groups (i.e., 0.55 of a standard deviation in the primary outcome).The analysis of the primary outcome was performed in accordance with the intention‐to‐treat (ITT) principle. Statistical analyses were computed on complete observed data and all randomized participants at all assessment times through the imputation of missing responses. Repeated‐measures linear regression models, including data at all time points, were used to estimate least‐square mean differences (with 95% two‐sided CIs) in the primary outcome at 2 years. The model included participant, treatment group, baseline score, time, interaction between time and treatment group, and the minimization variables. Participants were included in the complete case analysis if they had at least one response at any of the three assessment time points. In the analysis that took missing responses into account, multiple imputation was performed with the use of the Markov chain Monte Carlo method, which assumed a joint multivariate normal distribution. The imputation model was consistent with the analysis model.For the primary outcome, a Several sensitivity analyses for the primary outcome were also performed, including the following: the inclusion of time as a continuous linear predictor, assuming no interaction with treatment; the addition of a parameter for the treating hospital; and a per‐protocol analysis, including only those who received the allocated treatment. Some questionnaires were incomplete and, therefore, an additional sensitivity analysis used available subscale scores to generate an overall score.For the 4‐year data, continuous outcomes were analyzed by adding responses at this time point to the aforementioned regression models. For time to first pregnancy and time to first further procedure for treatment of fibroids, a Cox proportional hazard model was carried out, adjusting for the minimization variables. Kaplan–Meier plots were produced, in which women were censored if they had withdrawn, were lost to follow‐up, or had undergone a hysterectomy.The treatment effect on the primary outcome in pre‐specified subgroups that matched the minimization variables were analyzed involving adding the subgroup‐by‐treatment group interaction parameters to the linear regression model. All analyses were performed using SAS software version 9.4 (SAS Institute, Inc.,).Participants were randomized to undergo myomectomy or UAE in a 1:1 ratio. The stratification variables were used for the minimization details of the fibroids and whether the woman desired pregnancy. The demographic and clinical criteria were requested for each randomized participant. These procedures were performed according to the local guidelines and clinician's preference.The primary outcome was participant‐reported health‐related quality of life domain of the Uterine Fibroid Symptom and Quality of Life (UFS‐QOL) tool, which combines the assessment of symptoms as well as quality of life.Blood tests were obtained at baseline, along with various demographic and clinical criteria. Patients were allocated to treatment, either myomectomy or UAE, following the randomization process. These procedures were performed according to the local guidelines and clinician's preference.Secondary outcomes included loss of menstrual blood using the Pictorial Bleeding Assessment Chart (PBAC), pregnancy and related outcomes, patient acceptability, length of hospital stay, further treatments, assessment of ovarian reserve by measuring FSH, AMH, luteinizing hormone, serious adverse events, and complications. | PMC10107788 |
Assessment of menstrual blood loss | The loss of menstrual blood was measured using the PBAC. | PMC10107788 |
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Pregnancy outcomes | MISCARRIAGE | Pregnancy outcomes were recorded as specifically pregnancy (overall and in the population desiring pregnancy at the time of randomization) and outcomes (live birth, miscarriage, stillbirth, and termination). | PMC10107788 |
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Ovarian reserve | uterine artery embolization | BLOOD, UTERINE FIBROID | The ovarian reserve was measured by an assay of FSH, AMH, and luteinizing hormone. Hormonal levels were measured at baseline, 6 weeks, 6 months, and 1 year after the initial procedure. Blood samples were taken on day 2, 3, or 4 of the menstrual cycle.A total of 127 participants were assigned to the myomectomy group and 127 to the UAE group (Figure Flow of participants through the FEMME trial up to 2 years of follow‐up. LTFU, lost to follow‐up; UAE, uterine artery embolization; UFS‐QOL, Uterine Fibroid Symptom Quality of Life. | PMC10107788 |
RESULTS | SD, fibroid | FIBROID, COMPLICATIONS | The mean age of the patients was 41 years and they had a mean body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) of 28. There were no significant differences between the two groups with regard to demographics and in the number of women desiring pregnancy at randomization (UAE: 61 [48%]; myomectomy: 61 [48%]).The baseline characteristics of the trial participants are shown in Table The baseline characteristics of the trial participantsAbbreviations: BMI, body mass index; IQR, interquartile range; MRI, magnetic resonance imaging; SD, standard deviation; UAE, uterine artery embolization.Values are given as number (percentage), mean ± SD, or median (IQR).Minimization variable.More than one type of scan possible.More than one previous abdominal surgery possible.A substantial number of participants (38% in the UAE group and 43% in the myomectomy group) were of African Caribbean ethnicity and presented with a wide range of fibroid diagnoses. The rates of procedural complications were low in both groups, perhaps reflecting the expertise in the participating centers. | PMC10107788 |
Quality of life | Myomectomy resulted in a greater increase in the quality of life at 2 years, although improvement occurred in both groups (mean difference from observed data: 8.0 points, 95% CI 1.8–14.1; | PMC10107788 |
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Menstrual bleeding outcomes at 2 and 4 years | bleeding, amenorrhea | BLOOD, BLEEDING | There were no apparent differences between the groups in terms of menstrual regularity. There were regular or fairly regular cycles in 88% of the UAE group and 61% of the myomectomy group, and the difference was not statistically significant.There were no apparent and sustained differences in the bleeding scores, nor in the proportions of women reporting amenorrhea or heavy bleeding, between the two groups over the 2 years of follow‐up (Table Pictorial Blood Assessment Chart bleeding scores and categories within the first 2 yearsAbbreviations: CI, confidence interval; IQR, interquartile range; SD, standard deviation; UAE, uterine artery embolization.Estimates adjusted for baseline value and minimization variables.Scores ranged from 0 (no bleeding) to ∞ (worst bleeding); differences of <0 favor myomectomy.Relative risk for amenorrhea; estimates of >1 favor myomectomy.Relative risk for heavy bleeding; estimates of <1 favor myomectomy.Unadjusted model due to non‐convergence in adjusted model.PBAC bleeding scores and categories within 4 yearsAbbreviations: CI, confidence interval; IQR, interquartile range; PBAC, Pictorial Blood Assessment Chart; RR, relative risk; UAE, uterine artery embolization.Unadjusted model used because adjusted model failed to converge. | PMC10107788 |
Pregnancy outcomes | miscarriages | MISCARRIAGES, MISCARRIAGE | There were 22 pregnancies in total: 15 in the UAE group and 7 in the myomectomy group. Of the 14 women who reported pregnancies within 2 years of randomization, nine were in the UAE group and five were in the myomectomy group, representing 17% and 10% of participants, respectively, who expressed a desire for pregnancy at the time of randomization. Of these, there were six and four live births, respectively, and two miscarriages in the group allocated to UAE (Table Pregnancy outcomes within 2 yearsAbbreviations: CI, confidence interval; RR, relative risk; UAE, uterine artery embolization.Values are given as number (percentage) unless otherwise indicated.Estimates >1 favor myomectomy.One woman had two pregnancies that both ended in miscarriage and these have been reported once. | PMC10107788 |
Pregnancy outcomes at 4 years | EVENTS, MISCARRIAGE | The number of women becoming pregnant are reported as cumulative rates in Table Pregnancy outcomes at 4 yearsAbbreviations: ITT, intention to treat; UAE, uterine artery embolization.Values are given as number of women (number of events).UAE group: one participant had two pregnancies that both ended in miscarriage and two participants had two pregnancies that both ended in live birth. Myomectomy group: one participant had two pregnancies that both ended in live birth. These events have been primarily included once in this table, with repeat events in the same woman shown in brackets. All other events occurred in separate women. Percentages of the total population cannot be calculated, as women withdrew from the trial or were lost to follow‐up at different intervals up to 4 years.UAE group: one participant had two pregnancies that both ended in live birth. Myomectomy group: one participant had two pregnancies that both ended in live birth. These events have been primarily included once in this table, with repeat events in the same woman shown in brackets. All other events occurred in separate women. Percentages of the total population cannot be calculated, as women withdrew from the trial or were lost to follow‐up at different intervals up to 4 years.UAE group: one participant had two pregnancies that both ended in live birth. Myomectomy group: one participant had two pregnancies that both ended in live birth and one participant had two pregnancies that both ended in miscarriage. These events have been primarily included once in this table, with repeat events in the same woman shown in brackets. All other events occurred in separate women. Percentages of the total population cannot be calculated, as women withdrew from the trial or were lost to follow‐up at different intervals up to 4 years.Kaplan–Meier plot of time to achieve pregnancy in the two groups who were followed up beyond the end of the study to 4 years. It indicates that numbers overall were low over that time. The numbers in the UAE group continued to rise. UAE, uterine artery embolization.Hormonal markers of ovarian reserve over the 2 years of the study with no significant difference between the two groups
Abbreviations: AMH, anti‐Müllerian hormone; CI, confidence interval; FSH, follicle‐stimulating hormone; LH, luteinizing hormone; UAE, uterine artery embolization.Values are given as geometric mean (95% CI).Estimates >0 favor myomectomy. | PMC10107788 |
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Ovarian reserve | Hormone assay data are reported as geometrical means, unadjusted and adjusted for baseline scores and also age. There was no significant difference between the levels of hormones associated with ovarian reserve in each group. | PMC10107788 |
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DISCUSSION | bleeding, fibroids, fibroid, two‐thirds | BLEEDING, FIBROID, HEAVY MENSTRUAL BLEEDING, UTERINE FIBROIDS, COMPLICATION, FIBROIDS, OVARIAN FAILURE | While both procedures improved participant‐reported health‐related QOL scores, women assigned to the myomectomy group reported higher scores than those in the UAE group. The menstrual bleeding scores appeared similar in both groups. The overall complication rates for both procedures were low. The need for additional treatments was higher in the UAE group, and length of hospital stay was shorter in the UAE group. There were no consistent differences between the groups in biomarkers of ovarian reserve, and too few pregnancies in the present study to conclude the effect of the procedures on fertility.The doubling of the UFS‐QOL score from baseline to each time point shows that both treatments are effective, with some additional benefit accrued from myomectomy equating to a small to moderate standardized treatment benefit at 2 years.There were substantially more surgical re‐interventions in the UAE group within 2 years of follow‐up, possibly reflecting the higher residual impact on QOL observed in the UAE group and the marginal patient‐reported preference for myomectomy.Similar large improvements in UFS‐QOL scores have been reported after various fibroid treatments,Previous randomized trials that measured FSH, and used varying thresholds for ovarian failure, also found no evidence of harm from UAE over short and longer time frames.The present study is the largest ever randomized clinical trial to report on the treatment of symptomatic fibroids by UAE and any surgery. The robust study design ensures internal validity, enabling the results to be interpreted with confidence. In addition, the other measures reported above reflect the aspects of the condition of most importance to women.The techniques used for both myomectomy and UAE were determined by the fibroid presentation and the preference of the operating clinician. This enabled a diverse range of fibroid diagnoses to be included in the study. There was an 81% response rate for the primary outcome.There were a substantial number of women who were not recruited due to their preference for a particular treatment option, and the expectations of treatment benefit were not captured before randomization. All participants were analyzed in the groups to which they were allocated and the per‐protocol analysis gave a treatment effect very similar to the ITT population analysis, suggesting little impact of non‐adherence to the allocation.The two procedures have considerably different recovery periods, which may be reflected in the first outcome measures reported by participants at 6 months. The mean duration from randomization to the procedure was approximately 13 weeks in both groups, and the primary outcome was to compare QOL at 2 years postoperatively as a realistic time point.The present trial did not select patients based on their pregnancy intentions. The generalizability of the findings is increased by the inclusion of multiple centers, gynecological surgeons, and interventional radiologists. This allowed for the evaluation of the impact of both interventions without confounding by individual variance in clinical practice and skill, although nearly two‐thirds of participants were recruited from just three hospitals.Some blood samples were not analyzed as FSH and luteinizing hormone were not obtained within 5 days of the start of the last menstrual period. Despite randomization, there was a small difference in the age of participants between the two groups, prompting a post‐hoc adjusted analysis of the ovarian reserve markers.The data from the present study showed that myomectomy was cost‐effective in the UK healthcare settingUAE is now an established treatment for symptomatic fibroids but is mainly used in high‐income countries. The uptake in low‐income countries has been slow.The present study can form a solid evidence base in LMIC settings to support the studies arising from the regions themselves.In conclusion, both UAE and myomectomy are effective treatments for improving the QOL of women with symptomatic uterine fibroids. They both decrease the incidence of heavy menstrual bleeding equally. Neither treatment impacted significantly on measures of ovarian reserve.Myomectomy and UAE are both established procedures within the repertoire of many gynecologists and interventional radiologists, respectively, and the training of junior doctors should continue to include these procedures. Services should continue to offer both procedures to women where both are potential options. Women should be provided with the evidence generated by the FEMME trial to enable them to make a fully informed decision regarding their fibroid treatment. | PMC10107788 |
AUTHOR CONTRIBUTIONS | Fusun Sirkeci: investigation, writing (review and editing). Jane Daniels: conceptualization, writing (original draft), writing (review and editing), project administration, investigation, funding acquisition. Lee Middleton: statistical analysis plan, data curation, formal analysis, writing (review and editing). Versha Cheed: data curation, formal analysis, writing (review and editing). Isaac Manyonda: conceptualization, site principal investigator, writing (review and editing), investigation, funding acquisition. Anna M. Belli: conceptualization, site principal investigator, writing (review and editing), investigation, funding acquisition. John Moss: conceptualization, site principal investigator, writing (review and editing), investigation, funding acquisition. Olivia Wu: conceptualization, writing (review and editing), funding acquisition. Klim McPherson: conceptualization, statistical analysis plan, writing (review and editing), funding acquisition. Mary A. Lumsden: conceptualization, site principal investigator, writing (review and editing), investigation, funding acquisition. | PMC10107788 |
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FUNDING INFORMATION | The present study was funded by the UK National Institute of Health Research (NIHR) Health Technology Assessment (HTA) program (project number 08/53/22). | PMC10107788 |
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CONFLICT OF INTEREST | MAL reports personal fees from Gedeon Richter outside the submitted work (2018). All other authors declare they have no competing interests. All authors have completed the unified competing interest form at | PMC10107788 |
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TRIAL REGISTRATION | PMC10107788 |
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ACKNOWLEDGMENTS | A monograph reporting the data collected in the study has been published in the NIHR Journals Library. Further information is available at | PMC10107788 |
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DATA AVAILABILITY STATEMENT | Research data are not shared. | PMC10107788 |
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REFERENCES | PMC10107788 |
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Background | COVID-19 INFECTION | Patients with a history of COVID-19 infection may suffer from different physical problems. This study aimed to investigate the effect of corrective and breathing exercises on improving respiratory function among patients with a history of COVID-19 infection. | PMC10273547 |
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Methods | thoracic kyphosis, COVID-19 disease | In this clinical trial study, thirty elderlies with a history of COVID-19 disease were divided into two groups (mean age 63.60 ± 3.56 experimental, 59.87 ± 2.99 control groups) based on the study inclusion criteria. Exercise interventions included two sections- breathing exercises and corrective exercises in the cervical and thoracic spine. The spirometry test, craniovertebral angle, and thoracic kyphosis test were used. To evaluate differences between variables, paired-samples t-test and ANCOVA were used ( | PMC10273547 |
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Results | Results showed a significant difference between the two groups in craniovertebral angle ( | PMC10273547 |
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Conclusions | chronic pulmonary complications | COVID-19 INFECTION | The results showed the combination of corrective and breathing exercises could improve pulmonary function and correct cervical and thoracic posture in patients with a history of COVID-19 infection. Therefore, corrective and breathing exercises can be helpful as a complementary treatment along with pharmaceutical therapy to reduce chronic pulmonary complications in patients infected with COVID-19. | PMC10273547 |
Trial registration | This research was registered in the Iranian Registry of Clinical Trials (IRCT registration number: IRCT20160815029373N7, First trial registration: 23/08/2021, Registration date: 01/09/2021). | PMC10273547 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12906-023-04031-7. | PMC10273547 |
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Keywords | PMC10273547 |
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Background | respiratory diseases, respiratory distress, musculoskeletal problems, thoracic kyphosis | RESPIRATORY DISEASE, STILL, COVID-19 INFECTION, COMPLICATIONS | The older people are prone to a high risk of respiratory diseases, such as COVID-19 infection. The Covid-19 pandemic has induced significant physical and mental problems among old people [With aging, physiological changes occur that can affect the performance of various body organs, including the cardiorespiratory and musculoskeletal systems and posture [Therefore, performing breathing exercises, including those strengthening the respiratory muscles of the chest and boosting lung function (such as deep and calm breathing training, diaphragmatic breathing, and chest exercises) can improve the respiratory condition of affected people and mitigate the stress imposed on the respiratory distress and other related organs [In this regard, Liu et al. (2020) investigated the effect of six weeks of respiratory rehabilitation exercises on the respiratory function, quality of life, mobility, and psychological function of the elderly infected with COVID-19. The results showed significant improvements in FEV1, FEV1/FVC percentage, and the 6-min walking test in the intervention group after six weeks of respiratory rehabilitation [Clinical evidence has shown that proper respiratory rehabilitation can enhance the prognosis of recovered and discharged COVID-19 patients, maximize the preservation of lung function, and improve their quality of life. Still, there are insufficient studies in the world about the effectiveness of these interventions [In old people, the high rate of musculoskeletal problems and weak postures such as thoracic kyphosis, forward head, and round shoulder posture, can be associated with physiological complications such as reduced lung volume and respiratory capacity [ | PMC10273547 |
Methods | COVID-19 disease | DISEASE, RECRUITMENT | This was a parallel clinical trial. Via different types of announcements to the medical centers across Rasht City, we invited patients between 50–70 years old with a history of COVID-19 disease (six months after recovery from the acute phase of the disease and with a current negative the polymerase chain reaction (PCR) test) to take part in this study. All sample selection, disease diagnosis, and prescription of exercise protocols were performed under the direct supervision of a treatment team, including health specialists and experts. A total of 67 patients volunteered and then, they were evaluated based on the inclusion and exclusion criteria to find the final qualified group. From 67 volunteers, 40 people were eligible based on the inclusion and exclusion criteria. For determining the sample size, according to the study of Liu et al. [Regarding this continuous outcome variable, the sample size was calculated as 13 subjects per group with an average effect size of 50%, 95% confidence interval, and 80% study power. Due to the possibility of dropouts, the final sample size was determined Consort diagram of the study showing sample recruitment and allocation processes | PMC10273547 |
Inclusion criteria | The inclusion criteria consisted of: 1- six months after the definitive diagnosis of COVID-19 and any other acute condition, a current negative PCR test [ | PMC10273547 |
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Exclusion criteria | thoracic kyphosis, COVID-19 disease | DISEASE | The exclusion criteria included: 1- the diagnosis of any neurological or orthopedic disease during the study, 2- unwillingness to continue participation in this study, 3- contracting the COVID-19 disease again, 4- the occurrence of any medical problem affecting the safe implementation of the exercise protocol by the patient, 5- the need for starting physiotherapy during the study.In the experimental group, the subjects and their closest family members were practically trained in the clinic to perform the exercises correctly, including corrective and breathing exercises with supervising and monitoring the health staff. After the health staff ensured exercises were learned correctly by participants, an educational video (a CD) and illustrated instructions were provided to them. Participants' performance was periodically monitored. The experimental group both received their prescription drugs and performed eight weeks of supervised exercise at home (three sessions per week, 30–45 min in each session). The control group received only the necessary treatments prescribed by their physician,Dependent variables included chest width and depth (using a caliper), craniovertebral angle (using a goniometer), and thoracic kyphosis (using a flexible ruler), and were measured in pre-posttest sessions. Also, a spirometry test was performed to record the FEV1, FVC, SPO2, and FEV1/FVC ratio. | PMC10273547 |
Thoracic kyphosis assessment | shock, kyphosis | SHOCK | A 60-cm flexible ruler (KERING) measured the kyphosis angle. The ruler was placed between the second and the twelfth dorsal vertebra on the shock appendages of the subject to take the shape of the dorsal vertebra arch. Then, carefully and without changing the ruler’s position, it was placed on white paper to draw the shape of the arcs [ | PMC10273547 |
Craniovertebral angle | abnormal forward-head posture | To check the forward-head posture, the craniovertebral angle was determined by connecting a line from the ear tragus to the spinous appendage of the seventh cervical vertebra and measuring the angle between this line and the horizontal line passing through the spinous appendage. In the present study, a goniometer was used to evaluate this angle. A craniovertebral angle smaller than 51 degrees in the standing position was interpreted as a sign of abnormal forward-head posture, as noted by Kim et al. [ | PMC10273547 |
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Spirometry testing for evaluating respiratory capacity | The Forced expiratory volume in one second (FEV1), Forced vital capacity (FVC), FEV1/FVC ratio, and peripheral oxygen saturation (SPO2) were measured by spirometry to evaluate the pulmonary function and respiratory capacity. Patients were informed to avoid using medications for 24 h and meals for two hours before the test. The participant was seated and in a resting position half an hour before the test. The spirometry test was performed in the evening (between 4 p.m. and 8 p.m.) by the same expert and in the same place. During the test, the subjects were requested to sit on a chair and put a special nose clip on their nose. After taking a deep breath, a full exhalation was directed into the spirometer tube to record the curve. This procedure was repeated thrice, and the highest values were considered [ | PMC10273547 |
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Statistical methods | The normality of the data was assessed by the Shapiro–Wilk test. For testing the within-group comparison, paired t-test and for between-group comparison, covariance analysis (ANCOVA) were utilized. | PMC10273547 |
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Discussion | and back spine posture, kyphosis, COVID-19 disease | ASTHMA, SEVERE PERSISTENT ASTHMA, COMPLICATIONS, CHRONIC RESPIRATORY DISEASE | In our study on the elderly with a history of COVID-19 disease, the results revealed significant differences in postural (i.e., craniovertebral angle and thoracic kyphosis curve) and respiratory capacity (FEV1, FEV1/FVC, SPO2) between the experimental (performing corrective and breathing exercises) and the control group. Also, the Craniovertebral angle and the SPO2 showed a large effect size while the effect size of FEV1 was a moderate level.In this regard, head and back spine posture and respiratory capacity parameters significantly improved in subjects performing eight weeks of corrective and breathing exercises compared to the control group. In line with these findings, in the study of Gad et alTherefore, prolonged and chronic respiratory diseases, such as asthma, can induce contractile changes or muscle imbalances in the neck and shoulder. Compared to healthy people, patients with mild or severe persistent asthma maintain their head and shoulders more forward and show a lower level in the chest wall, internal shoulder rotation, and spine flexibility [Also, the tendency to adopt a bent posture (head forward and hyper kyphosis) is particularly common in old patients, which leads to undesired structural and functional changes, impaired performance of motor skills, and reduced adaptation of the patient to the environment [Therefore, corrective exercises in combination with posture correction training can reduce these complications and improve the volume, chest expansion, and pulmonary function as well. In line with this result, Jang et al | PMC10273547 |
Limitations | CORONAVIRUS | One of the limitations in this study was not comparing spirometry findings between COVID-19 patients and healthy individuals. Also, because of the coronavirus pandemic, access to a sufficient number of patients was difficult. However, we tried to select participants from both genders to diminish this problem. The lack of a follow-up procedure was the other limitation that could estimate the prolonged effects of the exercise program on patients. In addition, in the present study, like any other human research, the family environment and social and economic conditions of individuals can affect the results of the research. Therefore, the generalization of current results to the wider target population should be done cautiously. | PMC10273547 |
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Conclusion | chronic pulmonary complications, COVID-19 disease | According to the present study's findings, the combination of corrective and breathing exercises could improve pulmonary function and correct cervical and thoracic posture in patients with a history of COVID-19 disease. Therefore, it seems that a comprehensive training program, including corrective and breathing exercises, can be helpful as a complementary treatment along with pharmaceutical therapy to reduce chronic pulmonary complications in patients infected with COVID-19. | PMC10273547 |
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Acknowledgements | The authors gratefully thank all volunteers who participated and cooperated in this study. | PMC10273547 |
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Authors’ contributions | KFD | PS was the main responsible and designing the study. KFD helped with data interpretation, and revising the manuscript. SA helped with writing the first draft and analyzing data. SRRM helped with testing and training participants. All authors accept the responsibility for the accuracy and correctness of the contents of this article with the final approval of this article. | PMC10273547 |
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Funding | This research was supported by Youth and Sports General Directorate in Guilan Province, Rasht, Iran. | PMC10273547 |
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Availability of data and materials | All data generated or analyzed during this study are included in this published article. | PMC10273547 |
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Declarations | PMC10273547 |
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Ethics approval and consent to participate | All procedures performed in this study were approved by the ethics committee of Kashan University of Medical Sciences. Ethics committee reference number: IR.KAUMS.REC.1400.021 | PMC10273547 |
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Consent to publication | Not applicable. | PMC10273547 |
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Competing interests | The authors declare no competing interests. | PMC10273547 |
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References | PMC10273547 |
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Background | This study aims to histologically evaluate the efficiency of debris removal through activation of 2.5% and 5.25% NaOCI using laser, ultrasonic, and intracanal heating methods. | PMC10386604 |
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Methods | Sixty-four maxillary central incisor teeth were randomly divided into two groups according to the irrigation solution ( | PMC10386604 |
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Results | The effect of NaOCI concentration was statistically significant ( | PMC10386604 |
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Conclusion | The efficiency of root canal cleaning increases with higher NaOCI concentration. Activation of NaOCI also significantly enhances its effectiveness. | PMC10386604 |
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Keywords | PMC10386604 |
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Introduction | Sodium hypochlorite (NaOCI) is widely used as an irrigation solution in endodontics due to its favorable physicochemical and antibacterial properties [Passive ultrasonic irrigation (PUI involves avtivating irrigation solutions used ultrasonic tips operating at frequencies of 25–40 kHz. This method increases the effective surface area of the solutions through ultrasonic vibrations generated in the root canal, leading to more efficient cleaning [Therefore, the aim of this study is to histologically evaluate the efficiency of pulp residue and debris removal using both 2.5% and 5.25% NaOCI solutions, in combination with activation through laser, ultrasonic, and intracanal heating methods during the final irrigation step. | PMC10386604 |
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Materials methods | PMC10386604 |
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Ethical approval | Ethical approval for this study was obtained from the Institutional Review Board and the Ethics Committee of the University (2020/09–07). | PMC10386604 |
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Methodology | fractures, calcification | SMEAR LAYER | A total of 64 maxillary central incisor teeth with fully formed roots and closed apices were selected for his study. These teeth were extracted from individuals within the age group of 18–45 years for periodontal or orthodontic reasons. Prior to inclusion, the teeth were examined under a stereomicroscope, and any teeth with cracks or fractures were excluded. Only teeth without root canal calcification or resorption and with a minimum root length of 15 mm were included. Soft and hard tissue accumulations on the teeth were removed using a curette, and the teeth were stored in distilled water at room temperature until use. The teeth were decoronated using a slow-speed diamond saw with liquid cooling to obtain standardized root lengths of 15 mm. A size 10 K-type file was inserted into the root canal, and the working length was determined to be 1 mm shorter than the length visible at the apical foramen. The samples were randomly divided into two groups according to the concentration of NaOCI to be used during root canal instrumentation (Distribution of groupsAll samples were shaped up to X4 using the Protaper Next rotary file system(DenstplyMaillefer, Baillagues,Switzerland) and the X-Smart Plus (Dentsply Maillefer, Ballaigues, Switzerland) endodontic motor. Irrigation was conducted using 1 mL of either 2.5% or 5.25% NaOCI solution (Imicrly, Konya, Turkey) with a 31G side-vented needle during instrument change. Following instrumentation, the root canals were irrigated with 5 mL of 17% EDTA solution (ImidentTM Med., Konya, Turkey) for 1 min to eliminate the smear layer. No additional solution was utilized between the NaOCI irrigation and the subsequent EDTA irrigation. Afterwards, the samples were randomly divided into four subgroups based on the method of final irrigation activation ( | PMC10386604 |
Subgroup A: Er,Cr:YSGG laser | The root canals were filled with NaOCI solution and activated using Er, Cr: YSGG laser (Waterlase MD, Biolase Technology Inc., San Clemente, CA, USA) with an RFT2 tip. The tip, with a diameter of 275 microns in diameter and a length of 21 mm, was placed 1 mm short of the working length. The laser parameters were set to an output power of 2W, pulse frequency of 20 Hz, and a combination of 10% air and 10% water. The laser activation was performed in a slow and helical motion from the apical area to the coronal area for 8 s. The tip was positioned away from the dentinal walls and activated for 8 s, followed by a 10-s of deactivation period. This activation procedure was repeated 3 times, using fresh NaOCl solution for each cycle. | PMC10386604 |
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Subgroup B: passive ultrasonic irrigation | NaOCI was activated using ultrasonic device (VDW, Munich, Germany). The device was set to a power setting of 30, and activation was performed using a 21 mm-IRR20 irrigation tip placed 1 mm behind the working length. The tip was positioned away from the dentinal walls and activated for 20 s. This activation procedure was repeated 3 times, using fresh NaOCl solution for each cycle. | PMC10386604 |
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Subgroup C: intracanal heating | NaOCI solution was placed in the root canals and intracanal heating was performed using System-B device (11). System-B device was set to 150 | PMC10386604 |
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Subgroup D (control): Syringe-and-needle irrigation | strokes | STROKES | The root canals were irrigated with NaOCI solution using a 31-gauge closed-end needle (Ayset, Adana, Turkey), placed 1 mm short of the working length. The needle was moved in short vertical strokes with an amplitude of 2–3 mm at an approximate rate of 100 strokes per minute.A total of 5 mL of NaOCI solution was used for irrigation in all samples. The activation process was performed for a total of 1 min with 3 cycles of 20 s each (8 s active, 12 s waiting). The solution was refreshed for each activation cycle. Following the activation process, all samples were washed with 5 mL of distilled water and dried with paper points. | PMC10386604 |
Histological evaluation | DECALCIFICATION, DECALCIFICATION | After the completion of the endodontic procedures, all samples were fixed in 10% (v/v) neutral buffered formalin for 48 h and then washed under running tap water for 1 h. Decalcification of teeth was performed using a 5% nitric acid solution, with fresh solution being replaced every two days. The endpoint of decalcification was determined using a chemical method previously described in a study [Representative histological picture from root canals section; ( | PMC10386604 |
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Statistical analysis | The data were analyzed using IBM SPSS V23. The normal distribution of the data was assessed using the Kolmogorov-Smirnov test. The Generalized Linear Models method was used to evaluate the main effects of concentration and activation, as well as their interaction, on the amount of residual debris. Multiple comparisons were performed using the Bonferroni test. The results of the quantitative data analysis were presented as deviations. The level of significance was set at | PMC10386604 |
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Discussion | toxicity | SMEAR LAYER | This study investigated the effects of different concentrations of NaOCI solution and various final irrigation techniques on the remaining pulp and debris in the root canal. The results showed that the 5.25% of NaOCI solution provided significantly better cleaning in the root canal compared to the 2.5% of NaOCI solution. Furthermore, when NaOCI solution was activated during the final irrigation, laser activation demonstrated a statistically significant difference compared to passive ultrasonic activation and intracanal heating method. Activation of the 2.5% of NaOCI solution using laser, passive ultrasonic, and intracanal heating method did not yield as much cleaning efficiency as the 5.25% of NaOCI solution.Studies suggest that the toxicity of NaOCI increases with its concentration and that it should be used at the lowest effective concentration [When reviewing the existing literature, a consensus emerges that as the concentration of the NaOCI solution increases, its effectiveness also increases. Consequently, 5.25% NaOCI solution is commonly preferred in clinical practice. Additionally, in recent years, irrigation activation methods have been recommended to enhance solution effectiveness. This raises the question, “Is it possible to achieve the effects of high concentrations of NaOCI by activating low concentrations of NaOCI solution? Does this reduce toxicity?'' In this study, 2.5% NaOCI solution was activated using different methods during the final irrigation, and the results were compared with those of 5.25% NaOCI solution. However, the findings indicate that the cleaning efficiency of the high concentration NaOCI solution could not be achieved by activating the low-concentration NaOCI solution using laser, ultrasonic, and intracanal heating methods during the final irrigation. Activation at both concentrations improved solution effectiveness, with Er,Cr:YSGG laser activation demonstrating more effective cleaning in the canal compared to PUI and intracanal heating methods. Notably, the difference between PUI and intracanal heating was significant. Wang et al. [In recent years, researchers have shown interest in increasing the efficiency of NaOCl through heating. Heating the NaOCI solution enhances its flow and reaction rate, resulting in increased antimicrobial activity and tissue dissolution effect[NaOCI is commonly used as an irrigation solution in endodontic treatments due to its antibacterial activity and capacity to dissolve organic tissue. However, it does not have an effect on the inorganic components of the smear layer. Therefore, it is recommended to use proteolotic irrigants such as NaOCI in combination with chelating/calcifying agents like EDTA to remove the smear layer [Various methods are used to evaluate the cleanliness of root canals, including scanning electron microscope (SEM), optical microscope, computed tomography for pre/post instrumentation analysis, and histological analysis. However, none of these methods is considered ideal [ | PMC10386604 |
Acknowledgements | Not applicable. | PMC10386604 |
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Authors’ contributions | All authors contributed to the study conception and design. Material preparation and data collection were performed by Nesibe Zeynep Gökkaya and Ahmet Taşan. Histological analysis was performed by Eda Açıkgöz and Fikret Altındağ. Statical analysis and the first draft of the manuscript was written by Esin Özlek, and all authors commented on the previous versions of the manuscript. All authors read and approved the final manuscript. | PMC10386604 |
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Funding | This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. | PMC10386604 |
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Availability of data and materials | The datasets used and/or analysed during the current study available from the corresponding author on reasonable request. | PMC10386604 |
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Declarations | PMC10386604 |
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