Abstract
BackgroundGingival 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?DesignThe 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 registrationUniversal Trial Number U1111-1132-6655; German Clinical Trials Register DRKS00004248
Highlights
Gingival invaginations are a common side effect of orthodontic therapy, involving tooth extraction and subsequent space closure (Figure 1) [1]. They are defined as a cleft of the alveolar process with vertical and horizontal probing depth of at least 1 mm, occurring after tooth extraction and subsequent orthodontic space closure [2]
Data of an animal experiment [6] suggested that early tooth movement into an extraction site could be beneficial to prevent gingival invaginations, so atrophy of the alveolar process does not proceed
In group A the initiation of the orthodontic tooth movement will be performed in a time interval 2 to 4 weeks after tooth extraction versus tooth movement initiated in a time interval >12 weeks after extraction
Summary
Gingival invaginations are a common side effect of orthodontic therapy, involving tooth extraction and subsequent space closure (Figure 1) [1]. They are defined as a cleft of the alveolar process with vertical and horizontal probing depth of at least 1 mm, occurring after tooth extraction and subsequent orthodontic space closure [2] Their incidence is given in the range of 30% to 100% [3,4]. Data of an animal experiment [6] suggested that early tooth movement into an extraction site could be beneficial to prevent gingival invaginations, so atrophy of the alveolar process does not proceed In this clinical study we try to prove the hypothesis that a timely tooth movement into an extraction area could be beneficial and prevent the development of gingival invaginations.
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