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

Trials

Andreas Jäger³  Bert Braumann⁴  Dieter Drescher¹  Lina Gölz³  Christina Plötz³  Christine Fuhrmann⁵  Rolf Fimmers²  Martin Mengel⁵  Sven Scharf⁴  Manuel Nienkemper¹  Eric Kutschera³  Christoph Reichert³ 

[1] Department of Orthodontics, University Hospital Düsseldorf, Moorenstraße 5, 40225, Düsseldorf, Germany;Institute for Medical Biometry, Informatics and Epidemiology Bonn, Sigmund-Freud-Straße 25, 53015, Bonn, Germany;Department of Orthodontics, University Hospital Bonn, Welschnonnenstraße 17, 53111, Bonn, Germany;Department of Orthodontics, University Hospital Cologne, Kerpener Straße 32, 50931, Köln, Germany;Clinical Study Support Core, University Hospital Bonn, Sigmund-Freud-Straße 25, 53015, Bonn, Germany

关键词: Clinical trial;    Time;    Space closure;    Orthodontic tooth movement;    Tooth extraction;    Gingival invagination;   

Others  :  1094257
DOI  :  10.1186/1745-6215-14-108

 received in 2013-01-07, accepted in 2013-04-10,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Reichert et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

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