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Results
psychiatric
Greater severity in the psychiatric composite score was associated with substantially lower HRQoL, across all measures, following release from incarceration. Greater severity in the medical composite score was associated with lower pain/discomfort-related HRQoL.
PMC10210389
Conclusions
OUD
Our findings highlight the importance of ensuring individuals with OUD are linked not only to MOUD, but also treatment for their comorbid conditions upon release from incarceration.
PMC10210389
Supplementary Information
The online version contains supplementary material available at 10.1186/s13722-023-00375-0.
PMC10210389
Introduction
OUD, overdose
The U.S. Department of Justice estimated the number of incarcerated individuals under state and federal jurisdiction to be 1,430,800 at the end of 2019 [Initiation on OUD pharmacotherapy just prior-to, or immediately-following release from incarceration has been associated with increased rates of entry to community-based treatment [HRQoL is typically measured with self-report instruments designed to capture an individual’s well-being across multiple domains (e.g., physical, mental, emotional, etc.). Some HRQoL instruments are capable of generating an index value, based on the respondent’s combination of domain scores, which is intended to reflect their specific health-state at that point in time [Few studies have assessed HRQoL or QALYs among individuals with OUD who are also involved with the criminal-legal system, let alone over the time period directly before and after release from incarceration. Togas and colleagues examined the relationship between HRQoL, measured via the EQ-5D, and a variety of sociodemographic, health-related, and prison/facility characteristics, among the general male prison population in Greece [A recent trial by Woody et al. [Our research objective was to develop a better understanding of the factors that influence both the individual components, and the overall HRQoL among individuals with OUD during the high-risk transition period from incarceration to community. These nuanced findings could identify characteristics that would not only inform policies to reduce the threat of opioid overdose among this population, but also improve their general well-being during this critical period.
PMC10210389
Methods
PMC10210389
Study design and data
allergic, anxiety/depression, OUD, psychosis, abscess, depressive, psychiatric
ACTIVE TUBERCULOSIS, ABSCESS, ADVERSE EFFECTS, SECONDARY, CHRONIC PAIN, SEIZURE DISORDER
We conducted a secondary analysis of HRQoL among persons with OUD who were transitioning from incarceration to the community. Our analysis focused on the determinants of specific EQ-5D HRQoL domains, as well as the overall preference/utility score (please see description in Introduction), over the first 12 weeks post-release, with the first measure taken just before release, and treatment groups collapsed across condition.Data were obtained from the aforementioned Woody, et al. study, a 1:1 randomized trial, where participants with OUD who were incarcerated in the Philadelphia Department of Prisons were selected to receive either XR-NTX before release, with referral for continuing XR-NTX at a nearby community program after release (n = 74), or referral to start XR-NTX post-release, and receive continuing care at the same nearby program (n = 72) [Participants for the study had to meet the following inclusion criteria: be 18 years of age, or older; have a DSM-V diagnosis of OUD; be interested in and not allergic to XR-NTX treatment; plan to reside in Philadelphia for the next 6 months; be eligible for Medicaid or other third-party health insurance; anticipate release from incarceration within 3–4 months, with no subsequent sentence longer than 30 days scheduled at a different carceral facility; no residential treatment stay for over 30 days after release; give consent to be contacted; be proficient in English (speaking and reading); provide contact information of 3 references that could help locate the participant; not pregnant or breastfeeding; be eligible for treatment at the community treatment provider (NET Steps); be able to answer 9 out of 10 items on a study quiz,with three attempts allowed; no neurological, cardiovascular, renal, or hepatic conditions that could make participation hazardous; no active tuberculosis; not experiencing psychosis, suicidal thoughts, or homicidal tendencies; no uncontrolled seizure disorder; not on opioid therapy for chronic pain; and were not already sentenced to naltrexone.Data were collected from participants at baseline (pre-release), and at 12- and 24-weeks post-release. However, of the 146 randomized participants, 60 were lost after randomization due to unforeseen facility transfer, withdrawing consent, release prior to scheduled study induction, or becoming otherwise ineligible for study participation, leaving a final analytic sample of 86 (n = 38 pre-release XR-NTX; n = 48 referral only) [The parent study measured HRQoL via the EuroQol 5D (EQ-5D-5L) [Our outcome variables were the following longitudinal measures: a) categorical HRQoL measures of mobility, pain/discomfort, and anxiety/depression (usual activities and self-care were excluded because 97% and 98% of participant responses indicated “minimal difficulties” in these areas, respectively); and b) the previously-described preference/utility score associated with the participant’s health state. For ease of interpretation, the EQ-5D domain values were recoded such that an increase in values aligned with an improvement in the relevant health condition, similar to the utility score. As mentioned above, our analysis focused solely on the first two data collection timepoints, baseline and 12 weeks post-release, as the purpose of this study was to conduct an in-depth evaluation of the factors that influence HRQoL over this critical transition period for persons with OUD.Regression covariates included baseline sociodemographic variables (age, race, gender, high school completion, health insurance status), lifetime and past 30 days incarceration, randomization arm, and time-varying composite scores from the Addiction Severity Index (ASI) Lite (medical, employment/support, alcohol, drug, legal status, family/social relationships, psychiatric) [Additional predictors included injection drug use, and time free from opioids (measured in weeks). History of injection drug use was included in the analysis since prior studies have found significant associations between it and depressive components of various HRQoL scales, as well as between HRQoL and other adverse effects of injection drug use (e.g. abscess) [
PMC10210389
Analysis
anxiety/depression
REGRESSION
Separate, multivariable regression models were run for the three HRQoL domains with sufficient variation (mobility, pain/discomfort, anxiety/depression), and the overall utility score, between baseline (pre-release) and 12 weeks post-release; all covariates mentioned above were included in each regression model. Ordinal logistic regression was chosen to assess the HRQoL domains, given their ordered categorical nature [
PMC10210389
Addressing missing data
The study was subject to significant patient attrition. Prior analyses of the parent study data concluded that data was missing at random (MAR), and employed robust methods such as multiple imputation, to avoid bias [
PMC10210389
Results
PMC10210389
Significance between HRQOL domains and predictor variables
psychiatric
REGRESSION, REGRESSION
Table Multivariable Regression ResultsThe first 3 HRQoL Domains were analyzed using ordinal logistic regression and the HRQoL utility score was analyzed using OLS. IDU denoted injection drug use. Bolded values denotes statistical significance.Pain/discomfort was significantly associated with ASI medical (OR = 0.77; p < 0.001), ASI psychiatric (OR = 0.69; p < 0.001), and health insurance (OR = 0.24; p = 0.04). Specifically, a 1/10The ASI psychiatric composite score was inversely related to overall utility (p < 0.001), as measured via the EQ-5D, with a 1/10
PMC10210389
Discussion
psychiatric illness, psychiatric, OUD, anxiety/depression
DISORDER, CHRONIC PAIN, APPENDIX, COMPLICATIONS
Increased psychiatric complications, as measured by the ASI, were strongly associated with reduced HRQoL scores over the period immediately following incarceration, in all domains explored (mobility, anxiety/depression, pain/discomfort), as well as a relatively large decrease in overall utility. Although the ASI does not diagnose psychiatric illness, it does target problematic mental health areas in individuals with substance use disorder. Other studies have found a similar association between HRQoL and mental health among individuals with SUD, including OUD, [Increased severity of one’s medical condition was associated with a significant reduction in their HRQoL within the pain/discomfort domain, and was negatively correlated with their overall utility, but just outside of the traditional 5% threshold at p = 0.06. Given the high prevalence of chronic conditions among persons with OUD, particularly among those who are incarcerated, the results are not necessarily surprising. This is representative of previous literature which has shown that OUD is often associated with comorbid medical conditions, including chronic pain [Additionally, individuals with health insurance were more likely to have worse HRQoL in the pain/discomfort domain. As this result was not expected, further bivariate analyses were conducted to explore the potential causal mechanisms (Appendix Table Although not significantly associated with any of the individual HRQoL domains, family/social relationship issues were associated with slightly higher utility. This finding is in contrast to previous studies examining family/social relationships and HRQoL, which indicated that as family/social relationships improve, HRQoL improves as well, including among individuals undergoing treatment for OUD/SUD [The primary strengths of this study were the longitudinal and detailed nature of the data, which allowed us to analyze determinants of HRQoL at different time points surrounding an individual’s release from incarceration. Limitations of this study included the small sample size (n = 86), and the extent of missing data for the 12-week follow-up period. As discussed in the methods section and supplementary appendix, MICE was used to minimize potential bias arising from the missing data, and sensitivity analyses were conducted to evaluate alternative imputation methods. Furthermore, the racial/ethnic make-up of the study population was 62% Non-Hispanic White/Caucasian, 20% Non-Hispanic Black/African American, and 16% Hispanic-Puerto Rican, whereas according to the August 2022 Philadelphia Prison Population Report, the racial/ethnic make-up was 72.4% Black, 17% Latinx, and 9.3% White. This discrepancy likely limits the generalizability of our findings both within and outside of the Philadelphia Department of Prisons; however, there is little-to-no information regarding the racial/ethnic makeup of the incarcerated population with OUD.
PMC10210389
Conclusion
psychiatric, OUD
DISORDERS
Our findings highlight the importance of ensuring individuals with OUD are linked not only to MOUD, but also treatment for their comorbid conditions, particularly mental health disorders, upon release from incarceration. A holistic treatment approach for these individuals may be especially beneficial, given the estimated additive, independent effects of medical and psychiatric conditions on overall utility, as well as the potential benefits associated with care coordination [
PMC10210389
Acknowledgements
Not applicable.
PMC10210389
Author contributions
TC and SMM conceived of the study. TC had access to the study data, and conducted the statistical analysis. TC, SMM, AJ, and PJJ interpreted the results. TC wrote the manuscript first draft. All authors contributed to and approved the final manuscript. All authors read and approved the final manuscript.
PMC10210389
Funding
ABUSE
Grants R01DA046721, and P30DA040500 from the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH).
PMC10210389
Availability of data and materials
ABUSE
Statistical code: Available from Ms. Cadet (e-mail, [email protected]). Data set: Available in accordance with NIDA National Drug Abuse Treatment Clinical Trials Network policy (
PMC10210389
Declarations
PMC10210389
Ethics approval and consent to participate
Not applicable.
PMC10210389
Consent for publication
Not applicable.
PMC10210389
Competing interests
No competing interests to declare. Clinical trial registration: NCT02617628.
PMC10210389
References
PMC10210389
Purpose
This in vivo study aims to assess the pink esthetic score in the anterior maxilla after computer-guided immediate implant installation and fully digital immediate temporalization with and without grafting the jumping gap with a mixture of 1:1 autogenous and xenograft particulates.
PMC10644537
Materials and methods
upper anterior teeth, tooth, traumatic
Twenty-four patients with non-restorable upper anterior teeth in the aesthetic zone have undergone a traumatic extraction for the non-restorable tooth followed by immediate implant placement using a 3D-printed surgical guide according to prosthetically driven implant placement. The patients were divided into two groups. The study group received the dental implant after grafting the jumping gap with 1:1 autogenous and xenograft particulates, while the control group received the dental implant without grafting the jumping gap. Each patient received a digitally fabricated, immediate, nonfunctional temporary prosthesis. The esthetic outcome was compared between the two groups using the pink esthetic score at implant insertion and after 6 months of follow-up. Statistical comparisons were carried out between the studied groups using the Mann-Whitney U test.
PMC10644537
Results
PES
Immediately postoperatively, there was no statistically significant difference between the median PES in the two groups (P-value = 0.746). After six months, the study group showed a statistically significantly higher median PES than the control group (P-value = 0.048).
PMC10644537
Conclusions
Grafting the jumping distance in the immediate implant protocol helps achieve a better esthetic outcome.
PMC10644537
Clinical relevance
The use of immediate guided implant placement along with grafting the jumping gap followed by immediate digital temporalization guarantees a better esthetic outcome while preserving time, cost, and the number of clinical visits.
PMC10644537
Trial registration
The study was registered on clinicaltrials.gov with registration number NCT04096209. (19/9/2019)
PMC10644537
Keywords
Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC10644537
Introduction
angulation, bone loss, tooth
COMPLICATIONS, BONE LOSS
One of the main goals that modern dentistry strives to achieve is the successful and predictable restoration of missing teeth. Many materials and treatment modalities have been introduced for tooth replacement in the esthetic zone. The introduction of dental implants has brought this goal closer, leading to a revolutionary era for successful treatment [Immediate implant placement following tooth extraction has shown comparable survival rates to implants placed in healed alveolar ridges [Different techniques have been used for grafting the jumping gap such as Autograft based, Allograft-based bone which could be used alone or in combination with other materials for example: freeze-dried bone, Xenograft such as bovine bone, and Ceramic-based bone graft substitutes that include calcium phosphate, calcium sulfate, and bio-glass used alone or in combination [Bovine bone substitutes counteract many of the dimensional changes that occur in the post-extraction sockets. Bovine bone grafts act as an ideal barrier material, which in turn preserves the ridge width and volume and supports the soft tissue, preventing it from collapsing [The bone formation around an implant is an important factor for a better esthetic outcome; on the contrary, any bone loss means the loss of soft tissue, which in turn affects the ideal implant aesthetic result [With the advancement of computer-aided design and computer-aided manufacturing (CAD-CAM) technology, there are different approaches for implant prosthetics’ digital workflow [The CAD-CAM guided templates have many applications in dentistry such as implant placement and endodontic access preparations, the guided implant osteotomy presents an accurate protocol for implant placement in the preplanned position with less surgical time and few post-surgical complications. The digitally designed surgical guides transfer the virtually planned implant angulation, width and length through the use of 3D printed transparent template [Many debates with different opinions have existed regarding grafting or leaving the buccal jumping gap empty. Therefore, the primary purpose of this in vivo study was to evaluate the pink esthetic score in the maxillary esthetic zone after computer-guided immediate implant installation and fully digital immediate temporalization with and without grafting the jumping gap with a mixture of 1:1 autogenous and xenograft particulates.
PMC10644537
Materials and methods
upper anterior teeth, maxillary incisors, tooth
DIABETES MELLITUS, BONE DISEASES, DISEASES
The present parallel randomized control study was conducted following the ethical principles of the Helsinki Declaration for research on human subjects and was approved by the research ethics committee, faculty of dentistry, Cairo University (19)-(7)-(4). The study was registered on clinicaltrials.gov with registration number NCT04096209. It was first registered on September 19, 2019. Twenty-four patients with non-restorable upper anterior teeth in the aesthetic zone, indicated for extraction followed by immediate implant installation therapy, ages ranging from 20 to 50, were recruited from the outpatient clinic of the Oral and Maxillofacial Department, Cairo University.The inclusion criteria were patients with non-restorable single bounded maxillary incisors or canines that have completely intact labial plate and interproximal bone levels and are indicated for implant placement. All patients have adequate bone height apical to the failing tooth. All patients were free from any debilitating diseases such as bone diseases, diabetes mellitus, or any other diseases that affect dental implant osteointegration. Informed consent was obtained from all the participants in the study.The participants were randomly divided into two groups using block randomization with stratification (block size 4) using a formula on Microsoft Excel software.The sample size was calculated using G Power software and based on a previous study by Diana C. et al. [
PMC10644537
Designing surgical guides and temporary restorations
bite, CAD, STL
CAD
A Cone-Beam Computed Tomography x-ray (PaX-i3D Green; VATECH), with parameters of 120 kVp,37.07 MAs, and a 0.25 mm voxel size, was performed for each patient to obtain Digital Imaging and Communication in Medicine (DICOM) file. Intraoral scanning for both working and opposing arches, along with digital bite registration, was carried out using the (MEDIT i600; MEDIT Corp.) to create a standard tessellation language (STL) file.A tooth-supported surgical guide was designed according to the prosthetically driven implant placement concept. The design of temporary restorations was carried out using (Exocad, Dental CAD software) after virtual extraction of the non-restorable anterior tooth [ Virtual designing of the temporary prosthesisAfter superimposition of the patient’s STL and DICOM files using (Real guide 5.0 software 3DIEMME), and according to the bone width, length, and socket dimensions, the implants (implant direct Legacy; Malibu Hills Road, Calabasas Hills, CA, USA) with a diameter of (3.7–4.2 mm) and a length of (13–16 mm) were selected. (Fig.  Implant planning according to the prosthetically driven implant placement protocol Design of the implant placement surgical guideThe surgical guides and the temporary restorations were 3D printed using (clear resin, EPAX resin for the EPAX 3d printer) and (white porcelain-like resin, EPAX resin for the EPAX 3D printer), respectively.
PMC10644537
Implant placement
tooth
Atraumatic extraction of the tooth or remaining root using a No. 15c lancet and periotome to cut gingival fibers of periodontal ligaments was performed. In one case, we encountered a fractured root at the apical 1/3, where we carefully separated the root with a surgical bur mesiodistally (Cat eye slit technique) and removed each fragment separately. In another case, the remaining root was luxated but difficult to grip, so we removed it with a large manual file, which engaged the root canal and facilitated the root delivery. (Fig.  Atraumatic extraction of an endodontically treated remaining root using a large endodontic manual fileThe implants were then placed after sequential drilling using the surgical guide. Any implants recording initial stability less than 35 Ncm weren’t subjected to immediate loading and were excluded from the study. One experienced implantologist has performed all the implant surgical procedures.
PMC10644537
Pickup of the 3D-printed provisional restorations
Denture
The loading of the temporary abutments was carried out over the implants. Teflon was applied around the implant into the gingival sulcus to prevent the escape of any pickup material. The pickup of the 3D provisional crowns was done with self-cured acrylic resin (Denture Base Material; Vertex-Dental B.V.).The provisional restorations were then finished and highly polished to achieve a smooth surface to encourage gingival formation and growth and to avoid bacterial accumulation, especially at the site of gingival contour, using rubber cups, Buff wheels, and goat hair burs at the chairside to attain an S-shaped emergence profile. (Fig.  Immediate postoperative view after placing the 3D-printed temporary restoration
PMC10644537
Grouping
PMC10644537
Group I. (the intervention group)
Patients were treated with immediate implant placement with a mixture of 50% Xenograft bone (Geistlich Bio-Oss®; Pharma AG, Bahnhofstrasse 40 CH -Wolhusen) and 50% autogenous bone placed in the jumping distance till the soft tissue level. The provisional restoration that was previously picked up is then screwed in place and hand-tightened. Note that autogenous bone was collected by low-speed drilling (300 rpm without coolant) from within the socket, and the bone graft material is incorporated into the tissue zone, acting as a scaffold to support the ridge contour profile and peri-implant soft tissues. (Fig.  A bone mixture of 50% xenograft to 50% autogenous bone was used to graft the jumping gap in the study group
PMC10644537
Group II. (the control group)
Patients were treated with conventional implant placement without grafting the jumping gap, followed by hand tightening of the provisional restoration. (Fig.  Immediate implant placement without grafting the jumping gap in the control groupAll patients received postoperative antibiotics orally for 3 days. Patients were instructed to follow oral hygiene measures and to use chlorhexidine 0.2% mouthwash for 2 weeks. All patients were clinically evaluated at 1 week, 2 weeks, 1 month, and 6 months postoperatively.
PMC10644537
Pink esthetic evaluation
tooth [, PES, tooth
The Pink Esthetic Score (PES) is based on seven variables: distal papilla, mesial papilla, soft tissue contour, soft tissue level, deficiency of the alveolar process, and soft-tissue texture and color. Each variable was assessed with a 0-1-2 score, with 0 being the worst and 2 being the best. The mesial and distal papillae were evaluated for completeness, incompleteness, or absence. All other variables were assessed in comparison to a reference tooth, i.e., the contralateral tooth [
PMC10644537
Statistical methodology
Numerical data were explored for normality by checking the distribution of data and using tests of normality (Kolmogorov-Smirnov and Shapiro-Wilk tests). The Pink Esthetic Score data showed a non-parametric distribution. Data were presented as mean, standard deviation (SD), 95% confidence interval for the mean (95% CI), median, and range values. For parametric data, the student’s t-test was used to compare the mean age values in the two groups. For non-parametric data, the Mann-Whitney U test was used to compare the two groups. Wilcoxon signed-rank test was used to study the changes by time within each group. Gender data (qualitative data) was presented as frequencies and percentages. Fisher’s Exact test was used to compare gender distributions in the two groups. The significance level was set at P ≤ 0.05. Statistical analysis was performed with IBM SPSS Statistics for Windows, Version 25.0. Armonk, NY: 1BM C0rp.
PMC10644537
Results
PMC10644537
Demographic data
Regarding baseline demographic data; there was no statistically significant difference between mean age values in the two groups. There was also no statistically significant difference between the gender distributions in the two groups. The mean and standard deviation (SD) values for age in the study group were 30.5 (9.6) years old, with 3 (25%) males and 9 (75%) females, while in the control group, the mean and standard deviation (SD) values for age were 33.8 (12.5), including 6 (50%) males and 6 (50%) females with a minimum of 20 years old and a maximum of 50 years old. Table  Mean, standard deviation (SD), frequencies (n), percentages (%) and results of Student’s t-test and Fisher’s Exact test for comparison between demographic data in the two groups*: Statistically significant (p < 0.05)NS: Statistically not significant (p 
PMC10644537
Pink esthetic score comparison between the two groups (inter-group comparison)
PES
Immediately post-operatively, there was no statistically significant difference between the median PES in the two groups (P-value = 0.746, effect size = 0.13). After six months, the study group showed a statistically significantly higher median PES than the control group (P-value = 0.048, effect size = 0.859). Table  Descriptive statistics and results Mann-Whitney U test for comparison between PES in the two groups*: Statistically significant (p < 0.05)NS: Statistically not significant (p 
PMC10644537
Pink esthetic score changes within each group (intra-group comparison)
PES
In the study group, there was a statistically significant increase in PES after six months (P-value = 0.039, effect size = 0.596). In the control group, there was a statistically significant decrease in PES after six months (P-value = 0.035, effect size = 0.609). Table  Descriptive statistics and results of Wilcoxon signed-rank test for the changes in PES within each group*: Statistically significant (p < 0.05)NS: Statistically not significant (p > 0.05) Box plot representing median and range values for Pink esthetic score in the two groups (Circle represents outlier)
PMC10644537
Discussion
angulation, PES, tooth
COLLAPSE, CREST
Many treatment protocols and materials are available to replace a natural tooth immediately after extraction, but the best protocol is unclear, especially in the esthetic zone [The relationship between the time of implant placement and the time of extraction can be classified into delayed placement after complete bone healing, immediate-delayed placement after soft tissue healing, and immediate placement, which usually preserves the extraction socket walls [Mareque S. et al. reported in their systematic review that immediate implants and delayed implant placement protocols have similar results radiographically and concerning patient-reported outcomes [Atraumatic tooth extraction was done to decrease the amount of labial bone resorption and maintain the gingival contour, as reported in a previous study. It was observed that atraumatic tooth extraction combined with immediate implant placement provides harmony and aesthetics to the gum line; this is attributed to the preservation of the remaining labial plate of bone during extraction and maintaining the gingiva intact without laceration [When the implant is placed in a 3D position into the bone, there is usually a distance created between the outer surface of the implant fixture and the inner surface of the labial plate. This gap is referred to as the “jumping gap”. A study that identified the histologic outcome of leaving an excessive horizontal jumping gap of 4.2 mm buccolingual without bone grafting, it showed the presence of intimate bone contact until the last implant fixture thread, which is proof that an immediate implant in a socket with intact buccal bone will allow healing and osseointegration without the need for a bone graft [In the study group, the jumping gap was grafted with 50% xenograft bone and 50% autogenous bone, which was collected by low-speed drilling (300 rpm without coolant) from the socket, avoiding the need for any additional surgeries. A pilot study was conducted to compare the difference between high-speed and low-speed drilling in collecting the gold standard of autogenous bone from an intra-oral site without the downside of donor site morbidity and the need for additional surgery. The samples of bone obtained by low-speed drilling showed live cells under optical microscopy, while the bone harvested at high-speed drilling didn’t show either living cells or cell growth. Also, the perfect control of drilling depth as the serrations or marks on the burs are easily visible during drilling is another advantage of the low-speed drilling protocol [Xenografts play an essential role in alveolar bone preservation and can be used as a valuable tool to maintain the dimensions of the extraction socket as well as encourage osteo-conduction and space maintenance [The dual-zone therapy technique means that immediate implant placement into a fresh extraction socket is performed with immediate provisionalization, and the bone grafting material is used to fill the gap until bone level and extend to the soft tissue margin. Results of this therapy show a positive outcome regarding bone healing as well as soft tissue health, giving a satisfactory esthetic outcome. This technique is recommended to attain high esthetic results, especially valuable when the gap between the implant body and the internal wall of the buccal bone is greater than 1.5 mm [The implants were placed using computer-designed surgical guides according to the prosthetically driven implant protocol, which guarantees an ideal implant position. The ideal implant position and angulation would reduce the risk of facial mucosal margin recession, and the esthetic result would be favorable even in the deficient socket [The pink esthetic score (PES) assesses the soft tissue surrounding the implant at 7 points [In our study, the temporary crown was digitally fabricated with an S-shaped emergence profile for maximum extension into the coronal soft tissue around the interim, as reported by Gluckman [The mean results for PES for the study group were 11.58 ± 1.16 post-operatively and increased to 12.42 ± 1.44 after six months, and were 11.75 ± 1.71 post-operatively for the control group and decreased to 11.17 ± 1.53 after six months, which can be attributed to the preservation of the socket wall through the use of the bone graft, which in turn prevented the collapse of the soft tissue contour as reported previously by Noelken R et al. [Based on the results in the present study, it is recommended that whenever the bony dimensions allow immediate implant with provisionalization, if it is possible, it should be the best line of treatment since it greatly enhances the PES and preserves the emergence profile with a highly finished and polished temporary crown. Satisfactory aesthetic outcomes may be achieved with immediate implants placed after the extraction of teeth in the maxillary anterior area of the dentition.The limitations of this study are to investigate the most suitable immediate implant protocol in patients with a defective labial plate of bone and the relationship between long-term mucosal stability, and the position of the facial bone crest. Further research is needed to investigate the relationship between mucosal stability, the type of bone graft material used, and the position and thickness of the facial bone.
PMC10644537
Conclusions
Within the limitations of the presented study, the following could be concluded:1-Computer-guided immediate implant placement with immediate temporalization using digitally designed infra-occlusal provisional restoration is a viable option for immediate implant replacement in the esthetic zone.2-The socket is an ideal reservoir for the autogenous bone to thrive in.3-Grafting the jumping distance utilizing the Dual Zone Grafting technique helps achieve a better esthetic outcome.4-Guiding and maintaining extra bone and soft tissue volume around dental implants is the key to achieving and maintaining good soft tissue esthetics.
PMC10644537
Acknowledgements
The authors thank Professor Hussien El Charkawi (head of the prosthodontics department) for his valuable advice throughout conducting this research.
PMC10644537
Authors’ contributions
Sherine Osama El Ebiary (article approval, operator in all the practical work, manuscript Writing-concept- data collection). Mohammed Atef (concept- design-interpretation -data collection. Medhat Sameh Abdelaziz (Corresponding Author, writing of the manuscript-design- interpretation -software- article approval). Mohammed Khashaba (manuscript Writing- interpretation- article approval- statistics).
PMC10644537
Funding
This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB).
PMC10644537
Data Availability
All data generated or analyzed during the current study are included in this published article and its additional files.
PMC10644537
Declarations
PMC10644537
Ethics approval and consent to participants
The present study followed the Declaration of Helsinki for the ethical principles of medical research involving human subjects and was approved by the faculty of dentistry, Cairo University (19)-(7)-(4). Informed consent was obtained from all subjects and/or their legal guardians.
PMC10644537
Consent for publication
Not Applicable.
PMC10644537
Competing interests
The authors declare no competing interests.
PMC10644537
References
PMC10644537
Abstract
PMC10726803
Objectives
depression, acute stroke
ACUTE STROKE
To date, the effectiveness of acceptance and commitment therapy (ACT) for acute stroke patients has not been well recognized. The study aimed to discover the effectiveness of group‐based ACT in treating depression for acute stroke patients.
PMC10726803
Methods
depression, 140 acute stroke
We conducted a randomized controlled trial with 140 acute stroke patients with depression. The ACT intervention comprised seven sessions, of 45–60 min over 4 weeks. Data were collected pre‐ and post‐intervention and at 3‐month follow‐up, assessing depression, health‐related quality of life (HRQoL), psychological flexibility, cognitive fusion, sleep quality, and confidence.
PMC10726803
Results
depression, acute stroke
ACUTE STROKE
Overall, 99.3% of the included patients were assessed as having mild depression. The ACT intervention significantly reduced depression in acute stroke patients in comparison with the control group post‐intervention and at 3 months (partial
PMC10726803
Conclusions
depression, acute stroke, depressive symptoms
ACUTE STROKE
ACT is effective in treating acute stroke patients with depression, and the efficacy was maintained at 3‐month follow‐up.This study found that G‐ACT could significantly reduce depressive symptoms in patients with acute stroke, and the interventional efficacy was maintained at 3‐month follow‐up (partial Ƞ2 for this effect was 0.306), with similar benefits being observed for HRQoL‐MCS, sleep quality, psychological flexibility, cognitive fusion, and confidence, and that G‐ACT can be performed well by clinical nurses with sufficient training and support.
PMC10726803
INTRODUCTION
stroke, depression, acute stroke, depressive symptoms
STROKE, ACUTE STROKE
Expenditure on health care and mental health care is growing and posing serious challenges for governments around the world (Patel et al., Psychological interventions to build mental wellbeing can have a vital role in reducing the pressure and burden of illness (Slade, To date, three RCTs have reported the effectiveness of ACT for stroke patients, and both showed benefits. Firstly, Majumdar and Morris (Secondly, Niu et al. (Thirdly, Wang et al. (These three RCTs suggest that ACT may have efficacy in reducing depression following stroke. This study aims to test the effectiveness of ACT in a large hospital by implementing G‐ACT for acute stroke patients with depression and to evaluate changes in the quality of life, and sleep quality. To our knowledge, this is the first large trial in an acute stroke sample testing G‐ACT as the treatment of depressive symptoms following stroke.
PMC10726803
METHODS
PMC10726803
Design
SECONDARY
This was an RCT with a pretest–posttest design and two arms, in which a 4‐week G‐ACT intervention was compared to usual care. The primary and secondary outcomes were collected using interviews before the intervention and immediately after the intervention in hospital, and then again 3 months later (follow‐up assessment) over the telephone, at the outpatient clinic, or during a home visit. The study was approved by the Ethics Committee of PLA Rocket Force Characteristic Medical Center (KY2018005).
PMC10726803
Setting
acute stroke
ACUTE STROKE
This study was conducted at the PLA Rocket Force Characteristic Medical Center, which is a large hospital with acute stroke in‐patient treatment.
PMC10726803
Patients
mental illness, HAMD, drug abuse or dependence, cognitive impairment, stroke, neurological disorder, dementia, bipolar disorder, Acute stroke, psychiatric, psychotic symptoms, Depression
ACUTE STROKE, NEUROLOGICAL DISORDER, STROKE
Acute stroke patients who had been hospitalized at the PLA Rocket Force Characteristic Medical Center were recruited from August 2020 to February 2021. The inclusion criteria were as follows: (1) primary diagnosis of stroke with a confirmation of magnetic resonance imaging or computed tomography, and with the last onset within 2 weeks, (2) aged over 18‐year old, (3) scoring at least 8 on the Hamilton Depression Rating Scale (HAMD or HDRS) scale, (4) being conscious and able to verbally and effectively communicate with the researchers, (5) having primary school education level or above, (6) having signed informed consent, and able to participate in the group intervention on time. Exclusion criteria were as follows: (1) having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants, (2) a diagnosis of cognitive impairment as assessed by the Mini–Mental State Examination, (3) receiving a psychological therapy in the previous 3 months, or currently experiencing severe psychotic symptoms, and (4) a history of drug abuse or dependence or any neurological disorder other than a stroke.We assessed 693 patients for eligibility, of whom 140 were randomized and 70 received treatment within our study. Not meeting inclusion criteria or declining to participate were the main reasons for exclusion from the study.
PMC10726803
Randomization
STRUCK
One hundred and forty patients gave written informed consent for this study, based on the Declaration of Helsinki, and were randomly assigned to one of two groups: G‐ACT or control group. Two independent researchers who did not participate in assessing patients took charge of the randomization using the lottery method. Once a number has been selected, that particular number was struck off from the draw box. Sequentially numbered, opaque, sealed, and stapled envelopes were used to store the assignment results. The allocation process was concealed from other researchers who were responsible for assessing participants. The envelopes were opened only after the corresponding patient had completed the baseline assessment.
PMC10726803
Intervention
tearing, stroke
STROKE
The patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G‐ACT and usual care support. Based on the Hayes and Wilson (Session‐by‐session outline of acceptance and commitment therapy course.Getting to know stroke, from a broader perspectiveFamiliarity and creating therapeutic communication. Encourage patients to share their views about stroke, ask the patients to share where they get their information about stroke, health education, including the risk factors, outcome, and rehabilitation, creating the distinction between actions that are under our control and actions that are controlled by our mindEmbrace everyday life, be content with the presentEncourage the patients to express their feelings and thoughts, normalization of negative thoughts, strengthen the positive thoughts, focus on acceptance of unpleasant feelings without trying to avoid or suppress themObserve yourself and understand yourselfBy using self‐portrait, labeling, tearing off the label to teach the patients learn to observe and understand themselves, and recognize that “I'm who I am”Be aware of the present moment and embrace itGuide the patients to be aware of the present moment, and encourage them to describe their current feelings and embrace them, and reinforce positive beliefsIdentification of individual valuesHelp the patient identify individual values at present and establish a positive attitude to face the current situationSet goals and commit to actionHelp the patient develop specific goals based on value orientation, and identify targets in line with their current situation and commit to actionLearn how to relax, improve sleep qualityBy using abdominal breathing, relaxing music, soft, and slow language to let the patient relax, help them learn the relaxation technique and can practice it by themselvesThe group training sessions were performed and administered by two research nurses. Prior to the study, the 2 nurses completed an online ACT training course including 16 classes in Meilihua eHealth University, and received supervision from 2 clinical psychologists, who had 5 years of experience in ACT therapy and who participated in designing the intervention sessions as primary researchers in the study. Prior to the study, the two nurses delivered three whole G‐ACT intervention sessions with stroke survivors by themselves with supervision by one of the two clinical psychologists, and the results showed good interventional outcome.
PMC10726803
Primary outcome
PMC10726803
Depression
HAMD
The HAMD or HDRS (Hamilton,
PMC10726803
Secondary outcomes
PMC10726803
Health‐related quality of life (HRQoL)
Health‐related quality of life (HRQoL) was assessed using the Short Form Survey Version 2 (SF‐12v2) (Ware et al.,
PMC10726803
Psychological flexibility
The Acceptance and Action Questionnaire II (AAQ‐II) (Bond et al.,
PMC10726803
Cognitive fusion
The Cognitive Fusion Questionnaire (CFQ) (Gillanders et al.,
PMC10726803
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) (Buysse et al.,
PMC10726803
Confidence
stroke
STROKE
The confidence was assessed using the confidence after stroke measure (CaSM) (Horne et al., The posttest and follow‐up assessment were administered by a trained research assistant who was unaware of each patient's treatment allocation, and the patients were asked not to reveal to her the types of treatment that they received.
PMC10726803
Statistical analyses
SPSS software version 20 was used for data analysis. Pearson
PMC10726803
RESULTS
stroke
STROKE, CEREBRAL INFARCTION
One patient in the control group declined to complete the second assessment before discharge. Of the patients in the intervention group, 9 (12.9%) patients participated in 5 sessions, 21 (30%) patients participated in 6 sessions, and 40 (57.1%) patients participated in all sessions. Finally, 139 patients (91 males, 48 females; age: 61.91 years ±10.363) were included in the final analysis. There were no significant statistical differences in the demographic and clinical characteristics data (gender, age, marital status, educational level, occupation, monthly gross income, residence, medical insurance, stroke hemisphere, prior cerebral infarction, and NIHSS score [The demographic and clinical characteristics of the subjects (
PMC10726803
Primary outcome
depression, Depression
There was no significant statistical difference regarding the score of HAMD at pre‐intervention between the two groups (Estimated means of primary outcome across time by treatment condition. Abbreviation: HAMD, the Hamilton Depression Rating Scale.Repeated measurement analysis of variance of depression across time by treatment condition. ***
PMC10726803
Secondary outcomes
stroke
STROKE, SECONDARY
There were no significant statistical differences regarding the score of MCS, PSQI, AAQ, CFQ, and CaSM at pre‐intervention between the two groups (Estimated means of secondary outcome across time by treatment condition. Abbreviations: AAQ, the Acceptance and Action Questionnaire; CaSM, the confidence after stroke measure; CFQ, the Cognitive Fusion Questionnaire; MCS, mental component summary; PCS, physical component summary; PSQI, the Pittsburgh Sleep Quality Index.
PMC10726803
DISCUSSION
stroke, psychiatric, psychotic symptoms, depression, acute stroke
STROKE, ACUTE STROKE
This study found that the G‐ACT intervention significantly reduced depression in acute stroke patients when compared with the control group at post‐intervention and this difference persisted at 3 months, which echoes the findings of RCTs using G‐ACT with acute stroke patients (Niu et al., Most of the included patients were assessed as having mild depression with those having severe psychotic symptoms and who may need individual therapy or more specialized psychiatric treatments excluded from our study. The promising results suggested that G‐ACT was effective in patients with mild depression, which is similar to other reported findings (Bai et al., This study also found that significant G‐ACT intervention effects were observed for HRQoL‐MCS at post‐intervention which persisted at 3 months in acute stroke patients. However, there was no outstanding difference in the PCS scores between the two groups at any time point. The lack of effect of G‐ACT on PCS in our study was similar to Dewhurst et al. (This study assessed an ACT intervention change in psychological flexibility, and the findings indicated that G‐ACT could improve psychological flexibility significantly over time, which was similar to a review (Graham et al., The group training sessions in the study were delivered by two research nurses suggesting that the G‐ACT intervention can be delivered by non‐psychologists including nurses who provide health care for the longest time to patients. As the psychotherapy is not available for in‐patients in China, the results of our study have important clinical implications because it means nurses or other non‐psychologists can implement ACT for stroke patients to reduce depression or other symptoms. Future multicenter studies need to test this conclusion. The nurses in this study had online and face‐to‐face training from two clinical psychologists and delivered three practice sessions prior to the study, which is similar to Majumdar and Morris (
PMC10726803
Strengths and limitations
depression, psychiatric, acute stroke
ACUTE STROKE
To our knowledge, this is the first large‐scale trial which focused on testing the effectiveness of G‐ACT in treating depression for acute stroke patients. The results showed that G‐ACT could reduce depression, and the effect was still significant over time (partial This study has several limitations. The study was conducted in one center with mainly hospitalized patients with acute stroke whose length of hospitalization was mostly less than 1 month. Although the study increased the occurrences of G‐ACT per week, there were still some patients who were unable to complete all seven sessions at the hospital. Participation in the study was voluntary and excluded patients using psychiatric drugs including antidepressants or sedatives so that the sample may not have been representative of the overall population, and a single site limits the generalizability of the findings. Most of the included patients were assessed as having mild depression, and it might be expected that their mental health would improve along with the recovery of neurological function compared with those with severe or moderate depression (Niu et al.,
PMC10726803
CONCLUSION
depressive symptoms
ACUTE STROKE
This study found that G‐ACT could significantly reduce depressive symptoms in patients with acute stroke, and the interventional efficacy was maintained at 3‐month follow‐up (partial η
PMC10726803
AUTHOR CONTRIBUTIONS
PMC10726803
CONFLICT OF INTEREST STATEMENT
The authors declare that they have no conflicts of interest.
PMC10726803
FUNDING INFORMATION
Beijing Municipal Science & Technology Commission (Grant Number: Z181100001718041)
PMC10726803
PATIENT CONSENT STATEMENT
All included patients gave written informed consent for this study, based on the Declaration of Helsinki.
PMC10726803
CLINICAL TRIAL REGISTRATION
PMC10726803
PEER REVIEW
The peer review history for this article is available at
PMC10726803
ACKNOWLEDGMENTS
We thank all researchers and patients for their participation in the study. This work was funded by Beijing Municipal Science & Technology Commission (Grant Number: Z181100001718041).
PMC10726803
DATA AVAILABILITY STATEMENT
The datasets used and/or analyzed during the current study are available from the first author on reasonable request. The funding agency demands that the data cannot be shared publicly until 3 years after it has been collected.
PMC10726803
REFERENCES
PMC10726803
1. Introduction
end-stage knee osteoarthritis, OA, Pain, ±, muscle soreness, pain, knee arthroplasty, balance dysfunction, TKA, knee flexion and extension ROM, knee pain
We investigate the effect of a 1-week comprehensive foam rolling (FR) intervention program on knee pain, range of motion (ROM), and muscle function in patients with TKA.Thirty patients with TKA were randomly allocated to FR (n = 15) or control (n = 15) groups. The control group received only regular physical therapy. Patients in the FR group performed the FR intervention in addition to their regular physical therapy twice daily from postoperative weeks two to three (60 s × 3 repetitions × 2 times/day × 6 days: total = 2160 s). Pain score, knee flexion and extension ROM, muscle strength, walking function, and balance function were measured before and after the FR intervention. From the second to third postoperative weeks, there were significant improvements in all variables, and the reduction in pain score at stretching was significantly greater in the FR group (−26.0 ± 1.4; Total knee arthroplasty (TKA) can reduce pain and improve the knee joint’s range of motion (ROM) in patients with end-stage knee osteoarthritis (OA). However, previous studies have shown that TKA induces limited knee joint ROM and decreases motor functions, such as walking speed. It is also well-known that pain in the early postoperative period is associated with improved knee joint ROM, pain, and walking speed three months after TKA. Specifically, previous studies have shown a significantly slower walking speed and a significant impairment in the knee joint flexion angle in the early stance phase and knee joint extension angle in the middle stance phase in patients with TKA as compared with healthy subjects [Recently, foam rolling (FR) has attracted attention as a method for relieving pain and improving ROM in the sports field. It can be assumed that FR has a favorable effect in patients with TKA since no knee flexion is required, as is in stretching. Nakamura et al. showed that a single FR intervention could decrease muscle soreness and increase ROM in eccentrically induced damaged muscles in healthy participants [However, the effect of an FR intervention program on patients with TKA remains unclear. Regarding balance dysfunction, a previous study showed that 3% of post-TKA patients fall during hospitalization [
PMC9961826
2. Materials and Methods
PMC9961826
2.1. Experimental Design
knee flexion and extension ROM, pain
CONTRACTION
We used a randomized, repeated-measures experimental design to compare the effects of a 1-week FR intervention on patients with TKA. The FR intervention was performed from the second to third postoperative weeks (1 week). The FR intervention program consisted of 60s × 3 repetitions × 2 times/day × 6 days (for a total of 2160 s/week) performed on the knee extensors muscles by a physical therapist. Outcome variables were measured before (PRE) and after (POST) the FR intervention. We assessed knee flexion and extension ROM, pain (i.e., using a visual analog scale [VAS]), 10-m walk speed, timed up-and-go test (TUG), one-leg standing time, and maximal voluntary isometric contraction (MVIC) torques of the knee extensors.
PMC9961826
2.2. Participants
The study population consisted of 30 patients admitted to our hospital who underwent TKA for knee OA (The mean age of the FR group was 75.9 ± 6.0 years (range: 61–83 years), and the mean body mass index (BMI) was 26.8 ± 2.9 kg/m
PMC9961826
2.3. Regular Physical Therapy Intervention
knee flexion, TKA, pain
Regular physical therapy was started on the day after surgery. All participants performed wheelchair practice, ROM exercises, strength training, and walking training according to their pain and general conditions. Our TKA protocol is to perform walking exercises with a walker one week after surgery, with a goal of 90° knee flexion. Two weeks after surgery, patients practice walking with a T-cane with a goal of 100° knee flexion. Three weeks after surgery, the patient will practice climbing up and down steps to be discharged from the hospital. Physical therapy interventions were conducted for 40 min each in the morning and afternoon, for a total of 80 min.
PMC9961826
2.4. FR Exercise
TKA
Our TKA protocol performs wound extraction in the second postoperative week. After the physical therapist confirmed there were no problems with the wound, a roller massager (TheraBand, Akron, OH, USA) was used in the second postoperative week after the extraction. FR was performed for 60 s each in the order of anterior thigh, medial thigh, and lateral thigh without a break, starting from a site 5 cm above the nearest edge of the surgical wound toward the hip joint, in accordance with a previous study [
PMC9961826
2.5. Knee Flexion and Extension ROM Measurement
knee flexion and extension ROM
BLIND
The physical therapist measured knee flexion and extension ROM using a goniometer [The participant was laid in a supine position, and passive knee flexion and extension ROM that could be tolerated was measured. Measurements were performed on the bed. In this study, we were not able to blind the investigators to the intervention information. We have calculated the intraclass correlation coefficient (ICC) for knee flexion and extension ROM, and we confirmed the high reliabilities for knee extension and flexion ROM (ICC = 1.00 and 0.92, respectively).
PMC9961826
2.6. Pain Measurement
knee pain, pain
Before FR intervention was performed in the second postoperative week, the degree of pain was measured using the VAS during knee joint ROM measurement. The VAS allows patients to estimate knee pain by marking an X on a 100-mm line (0 mm for no pain, 100 mm for worst possible pain). The pain was defined as the pain at the maximum ROM the patient could tolerate. The VAS has the highest–retest reliability and has been shown to correlate with other tests of pain intensity [
PMC9961826
2.7. Walking Measurements
In the FR group, measurements were obtained before FR at two and three weeks postoperatively. Walking speed was measured using a stopwatch at a comfortable walking speed of 10 m. A 3-m spare path was set up at the start and end of each measurement line, and measurements were taken twice. For all variables, the average of two measurements was used for the statistical analysis. ICC (1, 2) were 0.979 in two weeks and 0.975 in three weeks postoperatively.
PMC9961826
2.8. Balance Measurements
Balance was measured using the TUG [
PMC9961826
2.9. Muscle Strength Measurement
We measured isometric knee extensor muscle strength using a handheld dynamometer (Micro FET 2; Nihon Medix, Chiba, Japan). Muscle strength measurements via HHD were performed by the same well-trained physical therapist with more than ten years of experience. The method was based on a previous study [
PMC9961826