Christoph Reichert1,2, Eric Kutschera3, Christina Plötz3, Sven Scharf4, Lina Gölz3, Rolf Fimmers5, Christine Fuhrmann6, Gerhard Wahl7, Bert Braumann4, Andreas Jäger3. 1. Department of Orthodontics, Rheinische Friedrich-Wilhelms University of Bonn, Bonn, Germany. c_reichert@web.de. 2. Department of Orthodontics, University Hospital Bonn, Welschnonnenstrasse 17, 53111, Bonn, Germany. c_reichert@web.de. 3. Department of Orthodontics, Rheinische Friedrich-Wilhelms University of Bonn, Bonn, Germany. 4. Department of Orthodontics, University Hospital Cologne, Cologne, Germany. 5. Institute of Medical Biometry, Informatics and Epidemiology, University Hospital Bonn, Bonn, Germany. 6. Clinical Study Support Core, University Hospital Bonn, Bonn, Germany. 7. Department of Oral Surgery, Rheinische Friedrich-Wilhelms University of Bonn, Bonn, Germany.
Abstract
OBJECTIVE: Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. METHODS: A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. RESULTS: A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. CONCLUSIONS: As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.
RCT Entities:
OBJECTIVE:Gingival invaginations are a common side effect of orthodontic extraction-space closure. The timing of initiating the closure of an extraction space varies greatly in clinical practice. In this multicenter pilot and randomized controlled trial, we prospectively investigated whether initiating space closure in the early stage of wound healing would benefit the incidence and severity of invaginations developing in the extraction sites. METHODS: A total of 368 patients were screened for indications to extract at least one mandibular premolar. Those recruited were randomly assigned to one of two treatment arms: initiation of space closure either 2-4 weeks (arm A) or ≥12 weeks (arm B) after tooth extraction. Clinical data regarding treatment process and periodontal tissue response were recorded during and after space closure and analyzed by a specialized biometrics unit. The study was performed under continuous surveillance by an independent study control center. RESULTS: A total of 74 extraction sites were analyzed. Regarding the incidence of gingival invaginations, there were no significant intergroup differences [p = 0.13; group A comprising 37/44 (84.1%) and group B 29/30 (96.7%) invaginated sites]. The same was true based on either maxillary (p = 0.52) or mandibular (p = 0.21) sites only, and the severity of the invaginations did not differ between the treatment arms. CONCLUSIONS: As to the incidence and severity of gingival invaginations, we did not notice any statistically significant differences between the two timeframes. Our data do, however, provide a basis to identify additional confounders and to improve the accuracy of case-load estimations for future trials.
Authors: Christoph Reichert; Eric Kutschera; Manuel Nienkemper; Sven Scharf; Martin Mengel; Rolf Fimmers; Christine Fuhrmann; Christina Plötz; Lina Gölz; Dieter Drescher; Bert Braumann; Andreas Jäger Journal: Trials Date: 2013-04-24 Impact factor: 2.279
Authors: David Stoppenbrink; Nikolaos Daratsianos; Eric Kutschera; Sven Scharf; Bert Braumann; Werner Götz; Andreas Jäger; Christoph Reichert Journal: J Orofac Orthop Date: 2019-06-03 Impact factor: 1.938