Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer

2020 ◽  
Author(s):  
Sasan Naraghi ◽  
Niels Ganzer ◽  
Lars Bondemark ◽  
Mikael Sonesson
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Contact Point ◽  
Three Dimensional ◽  
Final Analysis ◽  
Single Centre ◽  
Retention Capacity ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Anterior Teeth

Summary Background Retention of the maxillary anterior teeth is commonly recommended to maintain the teeth in their corrected positions. Both fixed and removable retention methods are used, but the certainty of evidence is low. Objective To evaluate post-treatment changes in irregularity of the maxillary six anterior teeth and single tooth contact point discrepancy (CPD) of three different retention methods. Trial design Three-arm parallel group single-centre randomized controlled trial. Materials and methods Ninety patients, 54 girls and 36 boys, were recruited to the study. The inclusion criteria were adolescent patients treated with fixed appliances at least in the maxilla. After gaining informed consent from the patient and their custodians, the patients were randomized to one of three groups: bonded retainer 13–23, bonded retainer 12–22, and removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization, prepared by an independent person, used blocks of 30. The primary outcomes were changes in single CPD and Little’s irregularity index (LII) measured on digitalized three-dimensional study casts before and after 2-year retention. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. Results The LII and CPDs increased slightly in all three groups without any statistically significant differences between the groups. The VFR group showed a small intercanine width increase and some more changes of canine rotations than in the other groups. Harms No harm was observed in any subjects and none of the patients needed retreatment. Limitations The trial was a single-centre study and short-term changes were evaluated. Conclusions All three retention methods showed equally effective retention capacity and all the changes found in the three groups were small and considered clinically insignificant. Thus, the null hypothesis was confirmed. All three methods can be recommended. Trial registration NCT04616755

scholarly journals Comparison of post-treatment changes with and without retention in adolescents treated for maxillary impacted canines—a randomized controlled trial

2020 ◽  
Author(s):  
Sasan Naraghi ◽  
Niels Ganzer ◽  
Lars Bondemark ◽  
Mikael Sonesson
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Contact Point ◽  
Final Analysis ◽  
Post Treatment ◽  
Single Centre ◽  
Randomized Controlled ◽  
Anterior Teeth ◽  
Retention Group ◽  
Interim Period

Summary Objective To evaluate whether retention is needed after orthodontic treatment of impacted maxillary canines. Trial design Two-arm parallel group single-centre randomized controlled trial. Materials and methods Sixty-three patients, 39 girls and 24 boys, were recruited to the study. The inclusion criteria were patients with at least one impacted or unerupted maxillary canine, and moderate irregularity of the maxillary six anterior teeth according to Little’s index (LI). After gaining informed consent from the patient and their custodians, the patients were randomized to one of two groups, i.e. to a non-retention group or a retention group. The randomization process was prepared and carried out by an independent person not involved in the trial and the randomization used blocks of 20 (10 + 10). Primary outcomes were changes in single contact point discrepancy, and LI measured on digitalized three-dimensional study casts 1-year post-treatment. The study casts were anonymized before assessment and the changes were blinded for the assessor. Data were evaluated on an intention-to-treat basis. Thus, all randomized patients were incorporated into the final analysis. In the non-retention group a 10-week interim period was used to detect patients who eventually have a relapse immediately after treatment. If so, the patient got the arch-wire reinserted. Most patients in the retention group received a vacuum-formed retainer and pretreatment spacing cases got a bonded retainer. Results Mean irregularity change was 0.4 mm in the retention and 1.3 mm in the non-retention group (P < 0.001). Maximum change was 2.5 mm in the retention and 3.2 mm in the non-retention group (P < 0.001). Most changes in the non-retention group occurred during the 10-week interim period. In the non-retention group, one patient developed contact point discrepancy of >2 mm during the interim period and was realigned. Harms One patient met the stopping guideline criteria. This patient had the arch wire reinserted for 2 months. After realignment, the patient received a retention appliance. Limitations The trial was a single-centre study and short-term changes were evaluated. Conclusions Changes between the retention and the non-retention group were statistically but not clinically significant. Since satisfactory clinical results 1-year post-treatment were found in the non-retention group, retention does not appear to be needed. The 10-week interim period was useful in detecting patients who might have a relapse immediately after treatment. Trial registration The trial was not registered.

Early headgear activator treatment of Class II malocclusion with excessive overjet: a randomized controlled trial

2020 ◽  
Author(s):  
Jenny Kallunki ◽  
Lars Bondemark ◽  
Liselotte Paulsson
Keyword(s):  
Randomized Controlled Trial ◽  
Early Treatment ◽  
Untreated Control ◽  
Controlled Trial ◽  
Class Ii ◽  
Control Group ◽  
Class Ii Malocclusion ◽  
Single Centre ◽  
Intention To Treat ◽  
Randomized Controlled

Summary Objectives To compare early headgear activator treatment of Class II malocclusion with excessive overjet with untreated control subjects in terms of the primary outcomes overjet and overbite as well as the effect regarding oral-health-related quality of life (OHRQoL), lip closure, incidence of trauma, and skeletal changes. Trial design Two-arm parallel group single-centre randomized controlled trial. Material and methods A total of 60 children (mean age 9.5 years) presenting a Class II malocclusion with excessive overjet were recruited. The trial was designed as intention-to-treat and the participants randomized by an independent person not involved in the trial to either early treatment with headgear activator or to an untreated control group (UG). Dental and skeletal variables as well as registrations of OHRQoL, lip closure, and incidence of trauma were recorded. For the treatment group, data were registered at baseline before treatment and when treatment was finished, corresponding to approximately 2 years. For the UG, registrations were made at baseline and at 11 years of age. Observers were blinded to treatment allocation when assessing outcomes. Results Early treatment with headgear activator significantly decreased overjet and improved molar relationship when compared with untreated controls. The effects were primarily due to dentoalveolar changes. Early treatment had no evident effect regarding OHRQoL, lip closure, or incidence of trauma. Lack of cooperation resulted in unsuccessful treatments for 27% of the patients. Limitations The trial was a single-centre trial and can thus be less generalizable. Conclusions The main treatment effect of early headgear activator treatment of Class II malocclusion with excessive overjet is reduction of overjet. Trial registration NCT04508322.

Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible—a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment

2019 ◽  
Vol 42 (5) ◽  
pp. 551-558 ◽  
Author(s):  
Anke Krämer ◽  
Mats Sjöström ◽  
Mats Hallman ◽  
Ingalill Feldmann
Keyword(s):  
Randomized Controlled Trial ◽  
Orthodontic Treatment ◽  
Controlled Trial ◽  
Three Dimensional ◽  
Retention Capacity ◽  
Randomized Controlled ◽  
Irregularity Index ◽  
Parallel Group ◽  
Part Time ◽  
Three Dimensional Models

Summary Background Evidence concerning the most appropriate retention strategy after orthodontic treatment is still inconclusive. Objective This trial compares the retentive capacity of vacuum-formed Essix C-retainers (VFR) and bonded cuspid-to-cuspid retainers (CTC) in the mandible 6 and 18 months after orthodontic treatment. Trial design A single-centre two-arm parallel-group randomized controlled trial. Methods This study included 104 adolescent patients, computer-generated randomized with sequentially numbered, opaque, and sealed envelopes into two groups and stratified by gender (52 females and 52 males). The patients were treated with fixed appliances with and without tooth extractions in both jaws and were ready for debond. In the intervention arm, patients received a VFR (n = 52); in the active comparator arm, patients received a CTC (n = 52). Dental casts were obtained at debond (T1), after 6 months (T2), and after 18 months (T3). The casts were digitized. The retentive capacity was evaluated on digital three-dimensional models using Little’s Irregularity Index (LII), overbite, overjet, arch length, and intermolar and intercanine width. Results Baseline values were similar for both groups. Statistically significant increases were noted in LII and overbite, mainly between T1 and T2, but also between T1 and T3 in the VFR group (LII = 0.52 mm, P < 0.001, overbite = 0.51 mm, P < 0.001) and in the CTC group (LII = 0.45 mm P < 0.001, overbite = 0.36 mm, P < 0.001). There were no significant differences between groups. Overjet showed small variations during the observation periods but was overall stable within and between groups after 18 months. Arch length decreased slightly in both groups after 6 and 18 months. Intermolar and intercanine widths remained stable after debond. Limitations Patients, operator, and outcome assessor could not be blinded due to the study design. Conclusions VFR and CTC have the same retention capacity in the mandible after 6 and 18 months. Relapse mainly occurs during the first 6 months of retention, but the post-treatment changes are generally small. Shorter VFRs in the mandible do not cause negative vertical effects. Part-time wear regimen is not associated with increased relapse. Trial registration NCT03070444.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019

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