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Background: The advertisement and adoption of untested orthodontic products is common. This study aimed to provide an update regarding the prevalence of clinical trials in orthodontics evaluating commercially marketed products. Associations between marketed/non-marketed products and study characteristics such as direction of effect, declaration of conflict of interest and industry sponsorship were evaluated. In addition, within the marketed products associations between direction of effect and study characteristics were explored., Material and Methods: Electronic searching of a single database (Medline via PubMed) was undertaken to identify Randomized controlled trials (RCTs) published over a 5-year period (1st January 2017 to 31st December 2021). Descriptive statistics and associations between trial characteristics were explored., Results: 196 RCTs were analysed. RCTs were frequently published in Angle Orthodontist (18.4%), American Journal of Orthodontics and Dentofacial Orthopedics (14.8%) and European Journal of Orthodontics (13.3%). 65.3% (128/196) of trials assessed marketed products after their introduction. The majority of trials assessed interventions to improve treatment efficiency (33.7%). Growth modification appliances were typically analysed in non-marketed compared to marketed products. An association between the type of product (marketed vs non-marketed) and both the declaration of conflict of interest and industry sponsorship was detected. For individual RCTs assessing marketed products either a positive effect (45.3%) or equivalence between interventions or between intervention and untreated control (47.7%) was evident. In 27% of these trials either no conflict of interest or industry funding was not clearly declared. Within the marketed products, no association between the direction of the effect and conflict of interest or funding was detected., Conclusions: The analysis of marketed orthodontic products after their introduction is still common practice. To reduce research waste, collaboration prior to the licensing and marketing of orthodontic products between researchers, industry and manufacturers is recommended., (© 2023. Italian Society of Orthodontics.)

Objectives: In this retrospective study we aimed to evaluate the quality of treatment outcomes using the American Board of Orthodontics (ABO) scoring system with a completely customized lingual appliance used in combination with a Herbst appliance for Class II correction., Materials and Methods: Patient selection criteria for this study were Class II division 1, II/2 or subdivision treated with a WIN® lingual appliance combined with an L-pin Herbst device. Thirty-two consecutively debonded cases were included in this retrospective case series. Pre- and post- treatment dental casts, dental set-ups, panoramic X-rays, cephalometric analysis, photographs and clinical files were available for data collection. The primary outcome was the ABO score based on the Discrepancy Index (ABO DI) including: overjet, overbite, anterior open bite, lateral open bite, crowding, occlusion (Angle class), lingual posterior crossbite, buccal posterior crossbite, ANB, IMPA and SN-GoGN angles and the Cast-Radiograph Evaluation (ABO CR-Eval) comprising of alignment/rotations, marginal ridges, buccolingual inclination, overjet, occlusal contacts, occlusal relationship (Angle class), interproximal contacts and root angulation. In addition, overjet, overbite and Class II correction were also evaluated on pre- and post-treatment models. The secondary outcome was bracket failure and complications related to the Herbst device., Results: The study cohort included 18 female and 12 male patients with a mean age of 15.8 (range 12, 6- 18, 5). Twenty patients were Class II division 1 and ten were Class II division 2. The mean pre-treatment value of ABO DI was 20.8 (range 10-39); more than two-thirds of the sample were rated as being either of moderate difficulty (ABO DI: 16-24) or severe (ABO DI: over 25). The average post-treatment ABO Cast-Radiograph Evaluation score was 15.0 (SD=4.4), which is considered a passing score. Twenty-six patients had a score equal or lower than 20 (undisputed passing score). The Class II discrepancy was effectively corrected from a score of 16.83 penalty points (SD: 3.65) pre-treatment to a score of 1.57 (SD: 1.70) post-treatment. No association was found between initial and final Class II occlusal relationships (P=0.42), indicating that regardless of the initial discrepancy, no difference in the success of Class II correction was observed. The mean bracket failure rate was 3.8 per patient. Herbst related complications were few: 1.6 per patient, with the majority of complications being of little consequence and with 43% of the patients having no breakages., Conclusion: The completely customized lingual appliance assessed in this study combined with an L-pin Herbst led to effective Class II correction regardless of the initial severity of the sagittal discrepancy. The average ABO CR-Eval score for this sample was well below the undisputed passing score indicating a high quality of treatment outcomes., (Copyright © 2020 The Authors. Published by Elsevier Masson SAS.. All rights reserved.)

Objectives: The purpose of this study was to investigate the quality of reporting of randomised clinical trials (RCTs) published in dental specialty journals., Methods: The journals possessing the highest impact factor (2008 data) in the six major dental specialties were included in the study. The contents of the 24 most recent issues of each journal were hand-searched and research articles identified as randomised controlled trials (RCTs) were selected. Quality evaluation was performed using the modified Consolidated Standards of Reporting Trials (CONSORT) statement checklist. The data were analysed using descriptive statistics followed by univariate and multivariate examination of statistical associations (alpha=0.05)., Results: Ninety-five RCTs were identified with generally suboptimal scores on quality reporting on key CONSORT areas. Significant differences were found among journals with the Journal of Clinical Periodontology achieving the highest score, followed by the American Journal of Orthodontics and Dentofacial Orthopedics. There was a positive association between quality score and number of authors, involvement of statistician/epidemiologist, and multicentre trials., Conclusions: The quality scores of RCTs in major dental journals are considered suboptimal in key CONSORT areas. This receives critical importance considering that improved quality of RCTs is a fundamental prerequisite for improved dental care., (Copyright 2010 Elsevier Ltd. All rights reserved.)