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Author contributions | TS and MT contributed to the study design, patient enrollment, study execution, manuscript drafting, and review. KK, KA, and ST contributed to the study design, data analysis, and manuscript review. Other authors contributed to patient enrollment and study execution. All authors reviewed and approved the manuscript before submission. | PMC10030450 |
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Funding | This study was supported by SymBio Pharmaceuticals Ltd.. | PMC10030450 |
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Data availability | The datasets generated and analyzed during the current study are not publicly available to preserve patient confidentiality; however, these will be made available by the corresponding author upon reasonable request. | PMC10030450 |
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Declarations | PMC10030450 |
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Ethics approval | This study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the institutional review boards of all participating sites. | PMC10030450 |
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Consent to participate | Written informed consent was obtained from all the participants included in the study. | PMC10030450 |
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Consent to publish | Permission to submit the manuscript for publication was obtained from all named authors. | PMC10030450 |
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Conflict of interests | EPS | ONCOLOGY | TS: speaker fees from Eli Lilly, Chugai, Taiho, and Boehringer Ingelheim; research grants from Novartis, Eli Lilly, Daiichi-Sankyo, AbbVie, Bristol-Myers Squibb, Eisai, AstraZeneca, Pfizer, Loxo Oncology, Takeda Oncology, Incyte, Chordia Therapeutics, 3D-Medicine, SymBio, PharmaMar, Five Prime, and Astellas; and advisory board fees from AbbVie, Daiichi-Sankyo, and Takeda Oncology. KN: speaker’s fees from Astellas, Takeda, Nanzando, AstraZeneca, Chugai, Roche Diagnostics, MSD, Eli Lilly, Nippon Kayaku, Ono, Merck Biopharma, Bayer, Daiichi Sankyo, Novartis, Kyowa Kirin, Taiho, Pfizer, AbbVie, Bristol Myers Squibb, CareNet, Amgen, Medical Review, Yodosha, 3H Clinical Trial, Thermo Fisher, Hisamitsu, Nichi-Iko, Kyorun, Medicus Shuppan, Nippon Boehringer Ingelheim, Nikkei Business, Yomiuri Telecasting and Medical Mobile; research grants from MSD, AstraZeneca, Pfizer, Icon, Astellas, Bayer, Takeda, Novartis, Eli Lilly, EPS, Bayer, Bristol Myers Squibb, CMIC Shift Zero, PRA HEALTHSCIENCES, Taiho, Eisai, Merck Biopharma, PAREXEL, Mochida, Covance, Ono, Kissei, Medical Research Support, Sysmex, GlaxoSmithKline, Sanofi, A2 Healthcare, Kyowa Hakko Kirin, Syneos Health, AbbVie Inc. EPS, Pfizer R&D, Chugai, Daiichi Sankyo, PPD-SNBL, Nippon Boehringer Ingelheim, IQVIA, Quintiles, Clinical Research and SymBio; consulting fees from Astellas, Takeda, Eli Lilly, Pfizer, KYORIN and Ono. HH: speaker fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eli Lilly, Kyorin, Merck Biopharma, MSD, Novartis, Ono, Shanghai Haihe Biopharm, Taiho, and Takeda; research grants from AstraZeneca, Boehringer Ingelheim, Chugai, and Ono; advisory board fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Chugai, Eli Lilly, Pfizer, Shanghai Haihe Biopharm, Takeda, and Merck Biopharma. TI: No conflict of interest. HK: speaker fees from Glaxo Smith Kline, Bristol-Myers Squibb, Eli Lilly, MSD, Ono, Chugai, Takeda, and Taiho; research grants from Chugai, Taiho, Kobayashi, and Eisai; consulting fees from Bristol-Myers Squibb, Eli Lilly, MSD, Ono, Daiichi-Sankyo, and Taiho; and honoraria from Bristol-Myers Squibb, AstraZeneca, Bayer, Eli Lilly, MSD, Ono, Chugai, Daiichi Sankyo, Merck Biopharma, Takeda, Yakult, and Taiho. SW: No conflict of interest. NY: speaker fees from AstraZeneca, Pfizer, Eli Lilly, ONO, Chugai, Sysmex, Daiichi-Sankyo, and Eisai; research grants from Astellas, Chugai, Eisai, Taiho, Bristol-Myers Squibb, Pfizer, Novartis, Eli Lilly, AbbVie, Daiichi-Sankyo, Bayer, Boehringer Ingelheim, Kyowa-Hakko Kirin, Takeda, ONO, Janssen Pharma, MSD, MERCK, GSK, Sumitomo Dainippon, Chiome Bioscience, Otsuka, Carna Biosciences, and Genmab; and advisory board fees from Eisai, Takeda, Otsuka, Boehringer Ingelheim, Cimic, and Chugai. KY: speaker fees from Eisai, Astrazeneca, Pfizer, Eli Lilly, Fuji Film, Chugai, Taiho, and Takeda; research grants from Daiichi Sankyo, Eisai, AstraZeneca, Pfizer, Eli Lilly, Fuji Film, Chugai, Taiho, Takeda, Sanofi, Genmab, Ono, Novartis, Boeringer Ingelheim, MSD, Seagen, and Nihon-Kayaku; and advisory board fees from Ono, Genmab, Novartis, Eisai, Chugai, Takeda, Daiichi Sankyo, and MSD. TK: Speaker’s fees from Sysmex and Chugai; research grants from PACT Pharma. JS: Speaker fees from AstraZeneca and Chugai. KT: Research grants from Pfizer, Eisai, Daiich-Sankyo, and Chugai. MT: Speaker fees from AstraZeneca, ONO, Chugai Novartis, Bristol-Myers Squibb, and Boehringer Ingelheim. KK, KA, and ST are full-time employees of SymBio Pharmaceuticals, Ltd.. | PMC10030450 |
References | PMC10030450 |
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Objective | sleep disorders | DISORDERS | Edited by: Mark Gold, Washington University in St. Louis, United StatesReviewed by: Lantie Elisabeth Jorandby, Lakeview Health, United States; Yi Zhang, Xidian University, ChinaThis article was submitted to Substance Use Disorders and Behavioral Addictions, a section of the journal Frontiers in Public HealthThe high rate of relapse has become the primary obstacle of drug rehabilitation. In this study, we explored the relationship between sleep disorders and relapse inclination in substance users, as well as the potential mediating mechanisms and corresponding interventions. | PMC9846318 |
Methods | sleep disorders | A total of 392 male substance users were recruited to complete the questionnaires on sleep disorders, quality of life and relapse inclination. On account of this, 60 participants with sleep disorders were randomly screened and allocated to the intervention and control groups. The former received 12 weeks of Health Qigong aimed at treating sleep disorders, whereas the latter performed their regular production work. | PMC9846318 |
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Results | sleep disorders, Sleep disorders | Sleep disorders had a positive effect on relapse inclination, quality of life was a potential mediator of this relationship, and 12-week Health Qigong designed to treat sleep disorders improved not only their sleep quality but also their overall quality of life, which in turn reduce the tendency to relapse. | PMC9846318 |
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Conclusion | Current research not only explores the high-risk factors influencing relapse, but also develops customized intervention strategies, which have theoretical and practical implications for decreasing relapse and increasing abstinence. | PMC9846318 |
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1. Introduction | Drug relapse refers to the use, intake, or abuse of psychoactive substances by substance users who have undergone withdrawal treatment and rehabilitation ( | PMC9846318 |
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1.1. Sleep disorders and relapse | substance abuse, Sleep disorders | DYSFUNCTION | Sleep disorders are the inability to get normal sleep in a suitable sleep environment. The most prominent clinical manifestations include difficulty in getting to sleep and maintaining sleep for a long time, waking up early and feeling tired after waking up, which sometimes lead to physical discomfort and even physical dysfunction (The neurobiological processes underlying sleep and substance abuse are intertwined, and alterations to one can have repercussions on the other ( | PMC9846318 |
1.2. The mediating role of quality of life | Quality of life refers to an individual's subjective evaluations about his life according to his cultural background and value system. It is shaped by each person's unique set of priorities, aspirations, and standards (Quality of life is not only a critical outcome variable, but also increasingly a determinant of the prognosis of substance users ( | PMC9846318 |
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1.3. Intervention effect of Health Qigong | weight loss | AIDS | A growing body of evidence supports the notion that exercise not only improves physical appearance, aids in weight loss, and increases muscle mass, but also has positive effects on mood, thinking, and other factors. However, recent studies have shown that participation in physical activity does not always yield positive outcomes ( | PMC9846318 |
1.4. The current study | sleep disorders, Sleep disorders | RELAPSE | In conclusion, the purpose of the current study was to investigate the relationship between sleep disorders and substance users' relapse, as well as the potential mediating mechanisms and corresponding interventions. The relapse inclination was used to predict the participants' post-treatment relapse behavior because they were all receiving mandatory isolation treatment in drug rehabilitation institutions and thus had no access to external drugs. Relapse inclination refers to the propensity of substance users to intake substances again after successful treatment. We proposed the following hypotheses in light of the literature review:H1: Sleep disorders of substance users will be directly associated with relapse inclination.H2: Quality of life will mediate the relationship between sleep disorders and relapse inclination.H3: Health Qigong intervention targeting sleep disorders could effectively improve sleep quality, enhance the quality of life, and then reduce relapse inclination. | PMC9846318 |
2. Materials and methods | PMC9846318 |
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2.1. Participants | PMC9846318 |
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2.1.1. Cross-sectional surveys (stage 1) | A total of 420 male substance users were recruited Descriptives of the sample. | PMC9846318 |
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2.1.2. Longitudinal Health Qigong interventions (stage 2) | sleep disorders | In accordance with the findings of the cross-sectional survey, 60 individuals with sleep disorders were randomly assigned to the intervention group or the control group. Exclusion criteria: ( | PMC9846318 |
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2.2. Measures | PMC9846318 |
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2.2.1. Pittsburgh sleep quality index | This scale is administered to evaluate the sleep quality of an individual over the past month ( | PMC9846318 |
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2.2.2. The MOS item short from health survey (SF-36) | It's used to assess the composite indicator of both physiological and psychological well-being ( | PMC9846318 |
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2.2.3. Relapse inclination questionnaire | This scale is used to determine the likelihood that participants would resume substance use after completing drug treatment ( | PMC9846318 |
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2.2.4. Intervention program and implementation of Health Qigong | sleep disorders, Yin deficiency | YIN DEFICIENCY | From the perspective of traditional Chinese medicine, the normal sleep-wake pattern is determined by the balance of Yin and Yang. Yin deficiency and Yang excess are the primary causes of sleep disorders. Moreover, the kidney is the source of Yin and is connected directly or indirectly to all body functions. To put it another way, sleep disorders stem from a deficiency of kidney Yin ( | PMC9846318 |
2.3. Procedures | sleep disorders | In the cross-sectional questionnaire study, the PSQI, SF-36, and RIQ were administered in groups. The PSQI score was applied to screen participants with sleep disorders for the longitudinal intervention study, and 60 of them were randomly assigned to the intervention group and the control group. Besides, the questionnaire's results were taken as pre-test scores. There were no significant differences in PSQI (17.46 ± 2.32 vs. 16.78 ± 3.14), SF-36 (456.64 ± 117.36 vs. 499.85 ± 133.36) and RIQ (1.59 ± 0.51 vs. 1.32 ± 0.57) between the intervention and the control group ( | PMC9846318 |
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2.4. Statistical analysis | PMC9846318 |
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2.4.1. Data from cross-sectional surveys | To begin, Harman single-factor test was used to check for common method bias because all variables were measured by questionnaires. Secondly, descriptive analysis and Pearson correlation were conducted for the main variables. Subsequently, the PROCESS plug-in is used to test the mediation model employing bias corrected percentile bootstrap CI. | PMC9846318 |
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2.4.2. Data from longitudinal interventions | sleep disorders | A 2 (group: intervention group, control group) ×2 (time: pre-test, post-test) two-factor mixed design analysis of variance was used to compare baseline and post-intervention scores on measures of sleep disorders, quality of life and relapse inclination between the intervention and control groups. Furthermore, correlation analysis was used to evaluate the relationships among the changes in PSQI, SF-36 and RIQ in the intervention group before and after the intervention to determine whether all variables altered to the same extent. | PMC9846318 |
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3. Results | PMC9846318 |
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3.1. Results of cross-sectional surveys | PMC9846318 |
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3.1.1. Common method deviation test | The Harman single factor test was used to examine the common method deviation. All the questionnaire items were included in exploratory factor analysis. The first factor explained 22.51% of the total variance, which was less than the 40% threshold, indicating that there was no common method deviation. | PMC9846318 |
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4. Discussion | PMC9846318 |
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4.1. Sleep disorders and relapse | sleep disorders, Sleep disorders | Consistent with previous research, sleep disorders positively predicted relapse inclination in substance users, which supported hypothesis 1. Sleep disorders have been linked to an increase in amphetamine's sensitization ( | PMC9846318 |
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4.2. The mediating role of quality of life | sleep disorders | This study further explored how sleep disorders contributed to relapse inclination and discovered that quality of life might be a mediator of this relationship, supporting hypothesis 2. The first path, wherein sleep disorders were negatively related to quality of life, was in line with previous research. According to the four-dimensional model of quality of life, there are four aspects of quality of life: physical health, mental health, social health, and spiritual health (The second path of the mediation model, wherein quality of life was negatively related to relapse inclination, was supported by relevant studies. After implementing a “community intensification” strategy to enhance the social and environmental quality of life for alcohol-dependent individuals, Hunter and Azrin discovered that participants had high rates of abstinence ( | PMC9846318 |
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4.3. Intervention effect of Health Qigong | sleep disorders, daytime dysfunction | In stage 2, we proved that Health Qigong intervention targeting sleep disorders could successfully enhance sleep quality, raise quality of life, as well as reduce the likelihood of relapse, thereby confirming hypothesis 3. Health Qigong for 12 weeks has been consistently confirmed to improve various aspects of sleep, including latency to sleep onset, total sleep time, efficiency of sleep, and daytime dysfunction, among others ( | PMC9846318 |
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5. Conclusion | sleep disorders | The current study identified sleep disorders is closely related to the relapse of substance users, and quality of life was a potential mediator of this relationship. In addition, a 12-week Health Qigong program designed to treat sleep disorders improves not only sleep quality but also the overall quality of life, which in turn reduces the tendency to relapse. | PMC9846318 |
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Data availability statement | The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation. | PMC9846318 |
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Ethics statement | The studies involving human participants were reviewed and approved by Ethics Committee of the School of Psychology at the Beijing Sport University. The patients/participants provided their written informed consent to participate in this study. | PMC9846318 |
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Author contributions | The intervention of Health Qigong was carried out by XW and AL. CS performed data analysis and carried out the bulk of the literature review and manuscript writing. XW and YS played an editorial role when it came to writing up the research study. Material preparation and data collection were performed by all authors. All authors contributed to the study conception and design and read and approved the final manuscript. | PMC9846318 |
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Funding | This study was funded by Guangxi Zhuang Autonomous Region Drug Rehabilitation Administration (Grant No. BSU20210330).Thanks to all the participants and volunteers who provided support for this study. | PMC9846318 |
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Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9846318 |
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Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC9846318 |
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Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC9846318 |
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References | PMC9846318 |
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Background | Most people’s tooth brushing performance is deficient, even when they are encouraged to brush to the best of their abilities. The aim of the present study was to explore the nature of this deficit by comparing best-possible vs. as-usual brushing. | PMC10327354 |
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Methods | PLAQUE | University students (N = 111) were randomly assigned to receive one of two instructions: “brush your teeth as usual” (AU-instruction) or “brush your teeth to the best of your abilities” (BP-instruction). Video analyses assessed brushing performance. The marginal plaque index (MPI) assessed after brushing was used as an indicator of brushing effectiveness. A questionnaire assessed subjectively perceived oral cleanliness (SPOC). | PMC10327354 |
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Results | PLAQUE | Participants in the BP group brushed their teeth longer (p = 0.008, d = 0.57) and used interdental devices more often (p < 0.001). No group differences emerged in the distribution of brushing time among surfaces, the percentage of brushing techniques used beyond horizontal scrubbing, or the appropriate use of interdental devices (all p > 0.16, all d < 0.30). Plaque persisted at the majority of the sections of the gingival margins, and the groups did not differ in this respect (p = 0.15; d = 0.22). SPOC values in the BP group were higher than those in the AU group (p = 0.006; d = 0.54). Both groups overestimated their actual oral cleanliness by approximately twofold. | PMC10327354 |
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Conclusions | Compared to their usual brushing effort, study participants increased their effort when asked to brush their teeth in the best possible manner. However, that increase in effort was ineffective in terms of oral cleanliness. The results indicate that people’s concept of optimized brushing refers to quantitative aspects (e.g., longer duration, more interdental hygiene) rather than qualitative aspects (e.g., considering inner surfaces and gingival margins, appropriate use of dental floss). | PMC10327354 |
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Trial registration | The study was registered in the appropriate national register ( | PMC10327354 |
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Supplementary Information | The online version contains supplementary material available at 10.1186/s12903-023-03127-3. | PMC10327354 |
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Keywords (MeSH) | Open Access funding enabled and organized by Projekt DEAL. | PMC10327354 |
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Background | PERIODONTAL DISEASE | Epidemiological studies have shown the prevalence of periodontal disease in Germany and worldwide [In line with the high prevalence of periodontal disease, however, several studies have shown that oral hygiene performance in a wide range of different age groups is inefficient in terms of oral cleanliness. Some studies also assessed brushing performance in terms of the distribution of brushing time across surfaces and sextants as well as of brushing movements [This raises the question, what do individuals change when they clean their teeth “as good as they can” instead of cleaning the teeth “as usual”? A better understanding of this can help to uncover patients’ misconceptions toward what constitutes a very good cleaning. As a first approach to answering this question, Deinzer et al. [This is a remarkable and disturbing result. This indicates that the patients’ concept of optimized brushing performance merely reflects an increase in brushing time. They do not seem to associate optimized brushing with an improvement in systematic brushing or with a change in the brushing technique in terms of brushing movements. However, prior to coming to such a conclusion, more research is needed. The former analysis [Thus, the aim of the present randomized controlled study was to compare the “best possible” vs. “usual” tooth brushing with respect to (a) brushing performance, (b) subjectively perceived oral cleanliness, and (c) objectively assessed oral cleanliness after brushing. The following three research hypotheses were tested: In comparison to the “brush as usual” instruction, the “brush to the best of one’s abilities” instruction will result in the following:
differences in brushing performance;better brushing outcome in terms of a higher degree of achieved oral cleanliness; and.a higher degree of subjectively perceived oral cleanliness. | PMC10327354 |
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Materials and methods | PMC10327354 |
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Study registration | This randomized controlled study has been registered at the German Clinical Trials Register ( | PMC10327354 |
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Ethics approval | The study protocol was conducted according to the principles of the Declaration of Helsinki and was approved by the local ethics committee (date 2019/01/23; No: 254/18) of the Medical Faculty of the University of Giessen. All participants provided informed written consent and were scheduled two different appointments between April 2019 and July 2019. The study had two objectives: the comparison of brushing as usual compared to the best of one’s abilities and the analysis of the stability of the brushing behavior within an interval of two weeks. The data presented here refer to the first objective. | PMC10327354 |
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Study sample | tooth | EVENTS, RECRUITMENT | Study participants were recruited via an internal mailing list of the Justus-Liebig-University Giessen and via online announcements of a regional newspaper. Inclusion criteria were being a student-resident of Giessen aged at least 18 to a maximum of 35 years as well as the predominant use of a manual toothbrush for at least six months (at least two-thirds of all tooth brushing events). Exclusion criteria were fixed orthodontic appliances, removable prostheses/dentures, oral piercings or dental jewelry, dental prophylaxis within the previous four months, pregnancy/lactation or use of antibiotics within the previous three months, and any training in a dental or medical profession. Sample size was calculated using G*Power 3, a free available power analysis program [
Flow diagram of participant recruitment, randomization, follow-up, and analysis | PMC10327354 |
Procedure | tooth | EVENT, DENTAL PLAQUE, PLAQUE | Students interested in study participation were contacted by telephone to provide detailed information about the study, and the inclusion/exclusion criteria were checked. Eligible students were scheduled for two appointments that were two weeks apart. While study participants were asked to brush their teeth at both appointments, plaque after brushing was only assessed at the second appointment. The present study therefore focuses on the data assessed at the second appointment.All participants were instructed to refrain from any oral hygiene behavior at least four hours before the appointments. Upon arrival at the laboratory rooms of the Institute of Medical Psychology, Justus-Liebig-University of Giessen, an assistant (A1) who was neither involved in the assessment of dental parameters nor the video recording while brushing welcomed the students and led them into the dental examination rooms. Dental plaque was assessed by one of the two dentists (TS or D2). Each dentist performed plaque assessments in 50% of the study participants. Afterward, A1 led the study participants to another room for tooth brushing where another assistant (A2) welcomed the participants. A2 accompanied them into an adjacent room equipped with a washbasin and a tablet computer with a front camera fixed at a tripod in front of the participants. This front camera served both as a mirror and as a recording tool for video recording of the participants’ tooth brushing performance. A red transparent sheet covered the surface of the tablet display to make plaque staining invisible for the participant. There were two side cameras at the walls for additional recordings used in case the tablet camera did not fully capture the brushing event. The participants were provided with a standard manual toothbrush (Elmex InterX short brush-head, medium; GABA, Loerrach, Germany) and toothpaste (Elmex; GABA, Loerrach, Germany). Additionally, dental floss (waxed and unwaxed dental floss; Elmex; GABA, Loerrach, Germany), super floss (Meridol Special-Floss; GABA, Loerrach, Germany) and interdental brushes (Elmex interdental brush sizes 2 and 4; GABA, Loerrach, Germany) were provided on a table beneath the basin. A2 informed the participants that these devices were at their free disposal. He then gave them the brushing instruction corresponding to their experimental condition (see below). Afterward, he asked them not to start brushing until they were told to do so over an intercom system. He then went to the adjacent room from which he started the video recording and repeated the respective instruction via intercom and asked them to start with tooth brushing. Participants communicated via intercom when they had finished their brushing. Immediately afterward, A2 led them back to the dental examination room where plaque was assessed again. At the end of the examination, participants were led to a neutral examination room and completed the questionnaire assessing their self-perceived oral cleanliness (SPOC) [ | PMC10327354 |
Independent variable/experimental conditions | BLIND | Participants were randomized to one out of two conditions, differing with respect to the instruction they received prior to tooth brushing. These were either “brush your teeth as thoroughly as you can so that they are completely clean” (arm 1; best of one’s abilities (BP)) or “brush your teeth as usual” “(arm 2; as usual (AU)) (instructions are translated from German; for original German instructions, see For randomization, A2 drew a lot with the respective instruction out of an opaque box. A2 was kept blind regarding the results of the dental examinations, as were the dentists regarding the experimental condition of the participant. To stratify with respect to participants’ sex and the examining dentist, lots were distributed to four boxes (one box for each dentist and each sex). | PMC10327354 |
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Outcome variables | tooth brushing | DENTAL PLAQUE | According to the three research hypotheses, three groups of outcomes were assessed: behavioral parameters of tooth brushing, objectively assessed dental plaque and subjectively perceived oral cleanliness. | PMC10327354 |
a) Observed tooth brushing performance | tooth brushing, tooth contact, tooth | PLAQUE | Assessment and video analyses of the behavioral parameters were conducted according to the procedures of previous studies (e.g., [Brushing parameters were as follows:
tooth contact time;brushing movements (circular, horizontal, vertical, modified bass technique);location of the brush with respect to surfaces (outer, inner, occlusal); andlocation of the brush with respect to sextants.Interdental hygiene parameters were as follows:
whether a device was used and, if yes, which device was used;number of interdental spaces processed; andappropriateness of flossing technique (i.e., guiding the floss between the teeth until reaching the gum line and curving it into a C shape against one tooth to clean the proximal tooth section).For each parameter, one examiner analyzed all videos with respect to this parameter and another who double-coded ten of the videos (see below). Altogether, seven examiners carried out the video analyses. All examiners were blinded to the experimental conditions. With respect to the clinical parameters, three examiners were completely blinded. Two of the examiners (TS, D2) were involved in the plaque assessment. To ensure their blinding as good as possible, there was a time gap of six to eight weeks between plaque assessment and video analysis. All examiners conducting the video analysis were calibrated before the beginning of the video observation. The calibration procedure was identical to previous studies (for details, see [The following additional parameters were calculated from the behavioral data obtained: proportional distribution of brushing time to outer, inner and occlusal surfaces (i.e., percentage of brushing time); proportional distribution of brushing time to horizontal, vertical, circular and MBT movements; and overall quality index for tooth brushing performance regarding the distribution of brushing time across sextants (QIT-S; see [ | PMC10327354 |
b) Objectively achieved oral cleanliness – dental plaque | PLAQUE, PLAQUE, DENTAL PLAQUE | An experienced dentist (D3) instructed and calibrated the examining dentists (TS, D2) prior to the study until at least 90% of the scores assessed by both examiners corresponded in five subsequent subjects (not involved in the present study) and the remaining deviated by no more than one. Dental plaque was assessed twice (before and immediately after brushing). Prior to each plaque assessment, dentists dried the teeth with an air stream and applied a plaque disclosing agent (Mira-2-Ton; Hager & Werken, Duisburg, Germany). Then, they assessed the MPI (Marginal Plaque Index, [ | PMC10327354 |
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c) Subjectively perceived oral cleanliness | To answer the question of how study participants subjectively assess their tooth brushing efficacy in terms of oral cleanliness, they completed the questionnaire for self-perceived oral cleanliness (SPOC) [ | PMC10327354 |
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Oral health status | Papillary Bleeding | For clinical description of the study groups, dental status (decayed, missing and filled teeth), the Papillary Bleeding Index (PB [ | PMC10327354 |
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Statistical analyses | Tooth, tooth | SECONDARY | The statistical analyses were carried out with the use of a statistical software package (IBM SPSS Statistics for Windows, Version 28; IBM, Armonk, New York, USA). Participants showing outlying values (defined as three standard deviations from the mean) in any of the behavioral parameters were excluded from final analyses to avoid distorted data. For data description, means and standard deviations and Cohen’s d as a measure of effect size were computed; in the case of skewed data, they were supplemented by quartiles and medians (shown in the The primary outcomes of research Hypothesis a) (brushing to the best of one’s abilities will lead to a different performance) were tooth contact time and time at occlusal and outer surfaces. Tooth contact time at inner surfaces, percentages of time by which the respective surfaces were brushed, percentages of time by which specific brushing movements were applied, and the QIT-S are the secondary outcome variables.The primary outcome of research Hypothesis b) (brushing to the best of one’s abilities will lead to a higher degree of achieved oral cleanliness) was the overall MPI. The percentage of surfaces scoring 3–5 (TQHI % 3–5 overall) was the secondary outcome variable.The primary outcome of research Hypothesis c) (brushing to the best of one’s abilities will lead to a higher subjectively perceived oral cleanliness) was the overall SPOC | PMC10327354 |
Results | One hundred and six participants finished the study (see Fig.
Characteristics of the sample | PMC10327354 |
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Group differences with respect to objectively achieved oral cleanliness – dental plaque after brushing (research Hypothesis b) | PLAQUE, PLAQUE | Plaque levels after brushing are shown in Fig.
Mean and standard error of the means of plaque assessed after brushing by the Marginal Plaque Index (MPI) overall and with respect to plaque at outer, inner, cervical and proximal sections (left panel); percentage of TQHI scores 3–5 referring to rather coronal aspects of the teeth (right panel). *p < 0.05 | PMC10327354 |
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Group differences with respect to perceived oral cleanliness (research Hypothesis c) | Data from one study participant are missing due to temporary internet failure. Analyses of subjectively perceived oral cleanliness (Fig.
Mean and standard error of the means of the subjectively perceived oral cleanliness overall and with respect to outer and inner surfaces. *p < 0.05 | PMC10327354 |
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Additional analyses | PMC10327354 |
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DMFT | Descriptive data of the DMFT show differences between the two groups, with a higher DMFT value in the AU group (Table | PMC10327354 |
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Interdental hygiene behavior | In total, n = 43 used interdental hygiene devices, with significantly more persons in the BP group than in the AU group (n = 31 vs. n = 12; exact p < 0.001). The majority of them (n = 38) applied dental floss, whereas only two of the AU group and three of the BP group applied interdental brushes. There were no group differences in the mean number of processed interdental spaces (mean ± SD: 18.42 ± 5.9 vs. 17.42 ± 6.4, respectively; p = 0.627). N = 4 in each group applied dental floss correctly. | PMC10327354 |
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Sensitivity analyses | SENSITIVITY | Exclusion of outlying data led to a shortfall in the target number of evaluable subjects (n = 91 instead of n = 102). Sensitivity analyses revealed that with the current sample size, an effect size of d = 0.52 (instead of d = 0.50) would be detectable with α = 5% and a power of 1-β = 0.80 [ | PMC10327354 |
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Discussion | gingivitis, tooth floss | PERIODONTITIS, GINGIVITIS, PLAQUE |
The instruction to brush to the best of one’s abilities led to an increased effort in the BP group. Their brushing time exceeded that of the AU group by nearly one minute (see Fig.
At this point, the question arises whether the increased effort shown by the BP group in terms of extended brushing time and an increased likelihood of interdental cleaning had a substantial impact on brushing success. The data are discouraging in this respect and are not in support of the research Hypothesis b). Overall plaque levels assessed immediately after brushing did not show significant group differences. Specifically, regarding the gingival margins, group differences were small. Furthermore, the more frequent use of interdental devices in the BP group did not improve their cleanliness in the proximal sections of the gum lines. Instead, plaque persisted in 80% of these sections. The toothbrush type used in this study has a crisscross design of the bristles and has been proven to be superior in its efficacy compared to other toothbrushes [
Improving one’s oral cleanliness thus requires more than an increase in brushing time and the application of tooth floss. However, people appear to have only these aspects in mind when they try to optimize their brushing behavior. In terms of dentistry, this appears to be a dysfunctional concept since it does not lead to better oral cleanliness. However, people themselves might consider it functional in that they believe that these behavioral changes would make a difference. This is exactly what the data show. The BP group rated their effectiveness even higher than the AU group. This supports research Hypothesis c). From their perspective, there appears to be no need for further changes, especially since they overestimate their oral hygiene in general. While objective plaque data indicate that less than 40% of the sections of the gingival margins were free from plaque, participants in the BP group thought it was 70%. Interestingly, both groups seem to be aware that they brush their inner surfaces less clean than their outer surfaces. Nevertheless, the BP group did not ameliorate the behavioral neglect of these surfaces in comparison to the AU group. This could indicate that during brushing, they have aspects such as time and interdental cleaning in mind rather than the oral cleanliness that they should achieve.
The current data may contribute to a better understanding of the apparent contradiction between the widespread implementation of oral hygiene as a daily routine and its low effectiveness in preventing gingivitis and periodontitis. Asking people to perform oral hygiene to the best of their abilities is a standard procedure to assess oral hygiene skills [
The current research has certain strengths. It is a randomized controlled study, which allows for firm causal inferences. It confirms the results of an earlier less controlled quasiexperimental study regarding differences in brushing behavior with respect to the instruction to brush as usual and to brush to the best of one’s abilities [ | PMC10327354 |
Conclusion | tooth brushing behavior | PLAQUE |
Instruction to brush teeth to the best of one’s ability results in a greater effort compared to brushing as usual. In particular, it leads to changes in the quantitative aspects of brushing (longer duration, more interdental hygiene) but not in the qualitative aspects, such as paying attention to the inner surfaces, cleaning the gingival margins or using dental floss appropriately. However, the increase in effort goes along with an increase in self-perceived oral cleanliness, which is not verified by objective plaque assessment. Emphasizing the qualitative aspects of tooth brushing behavior and raising awareness of hygiene deficits could be a first step toward improving the effectiveness of oral hygiene. | PMC10327354 |
Electronic supplementary material | APPENDIX | Below is the link to the electronic supplementary material.
Supplementary Material 1: Appendix | PMC10327354 |
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Acknowledgements | We greatly appreciate the valuable assistance of Dr. Waldemar Petker and Zdenka Eidenhardt in planning and conducting the research and video analysis. | PMC10327354 |
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Authors’ contributions | Conceived and designed the study: RD, UW, TS, JMS, BW. Data collection: TS. Statistical data analysis: UW. Video analysis: SS, TS. Data interpretation: UW, RD. Writing - original draft preparation: UW, RD, with the contribution of SS. Writing - review and editing: UW, RD. Read, revised, and agreed to be accountable for the manuscript: All authors. | PMC10327354 |
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Funding | The study was financed by the institutional budget of RD.Open Access funding enabled and organized by Projekt DEAL. | PMC10327354 |
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Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. However, for privacy reasons, no individual data allowing identification of participants (e.g., videos) can be provided. | PMC10327354 |
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Declarations | PMC10327354 |
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Ethical approval and consent to participate | All procedures were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Ethics Board of the Medical Faculty of the University of Giessen, Germany (No: 254/18). All participants provided informed written consent. | PMC10327354 |
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Consent for publication | Not applicable. | PMC10327354 |
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Competing interests | All authors declare that they have no conflicts of interest. | PMC10327354 |
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References | PMC10327354 |
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Objectives | To evaluate the clinical performance of self-assembling peptides versus fluoride-based delivery systems in post-orthodontic white spot lesions. | PMC9889428 |
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Materials and methods | The participants were randomly assigned into two groups ( | PMC9889428 |
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Results | GROUP B | There was a quantitative statistically significant difference via DIAGNOpen readings between Group A (fluoride material) and Group B (self-assembling peptides). The highest mean value of 10.51 was found in Group A, while the least mean value of 6.45 was found in Group B. Besides, there was a significant difference in each group concerning the time factors T0, T1, and T2 groups where ( | PMC9889428 |
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Conclusions | REGRESSION | The visual assessment using ICDAS reveals that the biomimetic remineralization using self-assembling peptides and the fluoride-based varnish material showed a similar effect in masking post-orthodontic white spot lesions. However, the laser fluorescence using DIAGNOpen showed that the self-assembling peptides reveal higher performance in subsurface remineralization than the fluoride-based varnish material. Therefore, self-assembling peptides are considered a promising material for lesion regression in post-orthodontics white spot lesions. | PMC9889428 |
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Clinical relevance | Self-assembling peptide SAP-14 is a new approach to reverse and mask off post-orthodontics white spot lesions. | PMC9889428 |
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Supplementary Information | The online version contains supplementary material available at 10.1007/s00784-022-04757-7. | PMC9889428 |
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Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC9889428 |
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Introduction | White spot lesions, chronic infectious diseases | DEMINERALIZATION, OPACITY, WHITE SPOT LESION, DENTAL CARIES, HYDROXYAPATITE | Dental caries is one of the most prevalent chronic infectious diseases, which remains a major public health concern. Dental caries passes through multi-stages, starting from molecular changes in the apatite crystal to visible white spot lesions, through to dentin involvement, and eventual cavitation. Advancement through these phases requires continual imbalance between pathological and protecting factors, resulting in the dissolution of crystals apatite and a net loss of calcium and phosphate which is known as demineralization [White spot lesions (WSLs), defined as “white opacity,” occur because of subsurface enamel demineralization that is located on smooth surfaces of teeth. The reason for the white appearance is the changes in light-scattering optical properties of the decalcified enamel. Various risk factors such as acid-producing bacteria, fermentable carbohydrates, and many host factors, such as poor oral hygiene, low salivary volume, and a sugary diet, further contribute to the development of these incipient lesions [Conservative dentistry no longer favors the “drill and fill” concept and supports the reversal of lesions via remineralization [Regenerative medicine-based dental approaches, where the damaged tissues are substituted with biologically similar tissues, hence shift from reparative to regenerative dentistry [On applying the P11-4-containing solution, P11-4 forms tapes and ribbons within seconds, and fibrils and fibers within the following 24 h under physicochemical conditions. These resulting self-assembling peptide fibers forming the 3D Self-Assembling Peptide Matrix (SAPM) can grow into a significant length of peptide diffusing into the lesion [In the lesion, it is thought to self-assemble spontaneously and produce 3-dimensional gels comprised of self-styled β-sheet aggregates. In this manner, the attachment of calcium and phosphate from saliva is supposed to be improved, so-called the body’s saliva-driven-remineralization. eventually de novo hydroxyapatite formation [Owing to the limited evidence-based data in the literature concerning the self-assembling peptide p11-4 in the management of white spot lesions, it was found that it will be goal-directed to assess the clinical performance of this recently introduced biomimetic material using a randomized controlled trial, to examine the null hypothesis that self-assembling peptide p11-4 will have the similar clinical performance as fluoride delivery systems in the management of white spot lesion after orthodontic treatment. | PMC9889428 |
Materials and methods | PMC9889428 |
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Trial registration and ethical approval | The protocol of the current study was registered on clinical trials with a unique identification number (I.D. NCT03930927.). Ethical approval was obtained before the start of the study. The study was approved by the Research Ethics Committee (CREC), Faculty of Dentistry with an ethical approval number (19754). | PMC9889428 |
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Sample size calculation | A study was planned to be of a continuous response variable from independent control and experimental subjects to evaluate the remineralization potential of self-assembling peptide P11-4 compared to fluoride vehicle material using laser fluorescence. In a previous study published in 2012 by Du et al. [ | PMC9889428 |
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Study design | A randomized controlled clinical trial, with two parallel groups designed with a 1:1 allocation ratio. The participants were randomly assigned into two groups (The examination was performed under direct illumination using a dental chair light after drying the teeth with compressed air for 5 s. All the participants were examined by the same examiner (S. H.) to avoid intra-examiner errors. All patients were selected according to inclusion and exclusion criteria to have non-cavitated white spot lesions. | PMC9889428 |
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Eligibility criteria | PMC9889428 |
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Patients eligible for the study complied with all the following: | carious white spot lesions [ | SYSTEMIC DISEASE, PLAQUE |
The patients’ age range between the age from 18 to 25 years old [Gender: males or females [Good oral hygiene with a plaque index score 0 or 1, good general health, and patient compliance [Active non-cavitated carious white spot lesions [Had completed fixed orthodontic treatment within the past 2 weeks [No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralizing process [ | PMC9889428 |
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