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Trials
Published in: Trials 1/2013

Open Access 01-12-2013 | Study protocol

Influence of time after extraction on the development of gingival invagination: study protocol for a multicenter pilot randomized controlled clinical trial

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

Published in: Trials | Issue 1/2013

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Abstract

Background

Gingival invaginations are a common side effect of orthodontic therapy involving tooth extraction and subsequent space closure. Consequences of gingival invaginations are a jeopardized stability of the space closure and hampered oral hygiene. In a retrospective study, the factor time until initiation of orthodontic space closure after tooth extraction has been identified as a potential risk factor for the development of gingival invaginations. The aim of this pilot study is to proof this hypothesis and to enable a caseload calculation for further clinical trials. The referring question is: is it possible to reduce the number of developing gingival invaginations by initiation of orthodontic space closure after tooth extraction at an early point of time?

Design

The intended pilot study is designed as a multicenter randomized controlled clinical trial, comparing the impact of two different time intervals from tooth extraction to initiation of orthodontic space closure on the development of gingival invaginations.
Forty participants, men and women in the age range of 11 to 30 years with orthodontically related indication for tooth extraction in the lower jaw, will be randomized 1:1 in one of two treatment groups. In group A the orthodontic tooth movement into the extraction area will be initiated in a time interval 2 to 4 weeks after tooth extraction. In group B the tooth movement will be initiated in a time interval >12 weeks after extraction. A possible effect of these treatment modalities on the development of gingival invaginations will be documented at the moment of space closure or 10 months +/- 14 days after initiation of space closure respectively, by clinical documentation of the primary (reduced number of gingival invagination) and the secondary endpoint (reduction of the severity of gingival invaginations).

Trial registration

Universal Trial Number U1111-1132-6655; German Clinical Trials Register DRKS00004248
Appendix
Available only for authorised users
Literature
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Gölz L, Reichert C, Jäger A: Gingival invagination–a systematic review. J Orofac Orthop. 2011, 72: 409-420. 10.1007/s00056-011-0046-z.CrossRefPubMed
2.
Reichert C, Gölz L, Dirk C, Jäger A: Retrospective investigation of gingival invaginations : Part I: clinical findings and presentation of a coding system. J Orofac Orthop. 2012, 73: 307-316. 10.1007/s00056-012-0082-3.CrossRefPubMed
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Rivera Circuns AL, Tulloch JF: Gingival invagination in extraction sites of orthodontic patients: their incidence, effects on periodontal health, and orthodontic treatment. Am J Orthod. 1983, 83: 469-476.CrossRefPubMed
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Robertson PB, Schultz LD, Levy BM: Occurrence and distribution of interdental gingival clefts following orthodontic movement into bicuspid extraction sites. J Periodontol. 1977, 48: 232-235. 10.1902/jop.1977.48.4.232.CrossRefPubMed
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Gölz L, Reichert C, Dirk C, Jäger A: Retrospective investigation of gingival invaginations : Part II: microbiological findings and genetic risk profile. J Orofac Orthop. 2012, 73: 387-396. 10.1007/s00056-012-0098-8.CrossRefPubMed
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Diedrich P, Wehrbein H: Orthodontic retraction into recent and healed extraction sites. A histologic study. J Orofac Orthop. 1997, 58: 90-99.PubMed
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Silness J, Loe H: Periodontal disease in pregnancy. Ii. Correlation between oral hygiene and periodontal condtion. Acta Odontol Scand. 1964, 22: 121-135. 10.3109/00016356408993968.CrossRefPubMed
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Saxer UP, Mühlemann HR: Motivation and education. SSO Schweiz Monatsschr Zahnheilkd. 1975, 85: 905-919.PubMed
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Metadata
Title
Influence of time after extraction on the development of gingival invagination: study protocol for a multicenter pilot randomized controlled clinical trial
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
Publication date
01-12-2013
Publisher
BioMed Central
Published in
Trials / Issue 1/2013
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-14-108

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