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

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

Gingivainvaginationen bei kieferorthopädischem Lückenschluss

“…Dementsprechend ist es aufgrund der Möglichkeit eines inkompletten Lückenschlusses, einer ästhetischen Beeinträchtigung und einer erhöhten Rezidivneigung empfehlenswert, Gingivainvagination durch Exzision zu entfernen [9]. Malkoc et al [12] [15].…”

Prospective Clinical Investigation of Orthodontic Relapse from Gingival Clefts

“…When looking at the periodontium, the most common occurring changes in orthodontic extraction cases are gingival recession, gingival overgrowth, and gingival invaginations ( Figure 1). [2,8]. Due to the compression and retraction forces at sites of extraction the interdental papillae may enlarge and accumulate resulting in gingival invaginations [9,10].…”

Evaluation of Periodontal Changes Adjacent to Extraction Sites during Upper Canine Retraction

“…Gingival invaginations display hyperplastic changes including epithelial hyper keratinization with pronounced depth proliferation at the edges of the invagination. [7][8][9] Stimulation from the orthodontic forces has been reported to be responsible for the hyperplastic tissue reaction. 10 Malkoc et al 11 attributed these histological changes to the interruption of the continuity of the gingival fiber system and bone remodeling that occur with destruction of the cortical plates, socket healing, and root movement.…”