Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction

A multicenter pilot and randomized controlled trial

Inzidenz und Ausprägung von Gingivaduplikaturen bei frühem vs. spätem Beginn des kieferorthopädischen Extraktionslückenschlusses

Eine multizentrische, randomisierte, kontrollierte klinische Pilotstudie

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.

Zusammenfassung

Ziel

Gingivaduplikaturen sind eine regelmäßig beobachtete Nebenwirkung des kieferorthopädischen Extraktionslückenschlusses. Im klinischen Alltag findet der Beginn des Extraktionslückenschlusses mit einer breiten zeitlichen Variation statt. Im Rahmen einer multizentrischen, prospektiven, randomisierten, kontrollierten Pilotstudie sollte untersucht werden, ob ein früherer im Vergleich zu einem späteren Beginn des orthodontischen Lückenschlusses nach Zahnentfernung Unterschiede bezüglich der Inzidenz und des Ausprägungsgrades entstehender Gingivaduplikaturen verursacht.

Methoden

Ein Screening von 368 Patienten wurde hinsichtlich einer Indikation zur Extraktion von mindestens einem Prämolaren des Unterkiefers durchgeführt. Nach Einschluss wurden die Patienten in einen von 2 Therapiearmen randomisiert: im Arm A wurde der Lückenschluss 2-4 Wochen, in Arm B frühestens 12 Wochen nach der Extraktion begonnen. Während und nach dem Lückenschluss wurden klinische Daten hinsichtlich des Therapieverlaufs sowie der parodontalen Gewebeantwort erhoben und der biometrischen Analyse zugeführt. Während der gesamten Untersuchung erfolgte kontinuierlich ein externes Monitoring.

Ergebnisse

Untersucht wurden 74 Extraktionsregionen. Es gab keine signifikanten Unterschiede hinsichtlich der Inzidenz der Gingivaduplikaturen: Gruppe A 37/44 (84,1%), Gruppe B 29/30 (96,7%); p = 0,13. Diese Ergebnisse waren auch im Vergleich der Einzelkiefer konsistent (Oberkiefer p = 0,52; Unterkiefer p = 0,21). Ebenfalls zeigte der Ausprägungsgrad der Gingivaduplikaturen keine signifikanten Unterschiede.

Diskussion

Diese Studie zeigte keinen signifikanten Einfluss der Heilungsphase vor dem Extraktionslückenschluss auf die Inzidenz und den Grad von Gingivaduplikaturen. Allerdings ist es möglich, mit den vorliegenden Daten weitere Einflussparameter zu identifizieren und genauere Fallzahlschätzungen für künftige klinische Studien zu planen.

Diese Untersuchung wurde durch die Deutsche Forschungsgemeinschaft (DFG RE3425/1-1), Universal Trial Number U1111-1132-6655) gefördert.

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Acknowledgements

This investigation was funded by the German Research Foundation (DFG; RE3425/1-1). Its Universal Trial Number is U1111-1132-6655.

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Correspondence to Christoph Reichert.

Ethics declarations

This study was conducted in line with the requirements of the institutional review boards, national law, and the 1975 Declaration of Helsinki as revised in 2013. All patients and their legal representatives had been informed about the study and had consented to participate orally and in writing. The study was registered in the German Clinical Trial Register (U1111-1132-6655). The study protocol is part of the GEPRIS database (http://gepris.dfg.de/gepris/projekt/228530729) and has been published in advance (Reichert et al. Trials 2013, 14:108 doi:10.1186/1745-6215-14-108). Funding for the study was obtained via a separate grant proposal (RE3425/1-1) from the German Research Foundation (DFG).

Conflict of interest

C. Reichert, E. Kutschera, C. Plötz, S. Scharf, L. Gölz, R. Fimmers, C. Fuhrmann, G. Wah, B. Braumann, and A. Jäger declare that they have no competing interests.

Additional information

This manuscript is laureate of the Arnold Biber Prize and honored with 5000 EUR.

Priv.-Doz. Dr. Christoph Reichert

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Reichert, C., Kutschera, E., Plötz, C. et al. Incidence and severity of gingival invaginations associated with early versus late initiation of orthodontic space closure after tooth extraction. J Orofac Orthop 78, 415–425 (2017). https://doi.org/10.1007/s00056-017-0098-9

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Keywords

  • Gingival invagination
  • Orthodontic space closure
  • Tooth extraction
  • Randomized controlled trial

Schlüsselwörter

  • Gingivaduplikaturen
  • Kieferorthopädischer Lückenschluss
  • Zahnentfernung
  • Randomisierte kontrollierte Studie