Pilot Study on early space closure to prevent gingival invaginations

在一项回溯性研究中，拔牙后至正畸间隙关闭的时间因素已被确定为牙周凹陷发生的潜在危险因素。这项先导性研究的目的是验证这一假设，并为进一步的临床试验提供病例数量计算。参考问题是：是否有可能通过在拔牙后早期开始正畸间隙关闭来减少发生牙龈内陷的数量？在一项随机研究中，正畸间隙关闭将在两个不同的时间间隔开始。通过记录主要终点(减少的牙龈内陷次数)和次要终点(降低牙龈内陷的严重程度)，将在初级读数(促进间隙关闭时刻)记录可能的影响。

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 in a retrospective study. The aim of this pilot study is to proof this hypothesis and to enable a caseload calculation for further clinical trials. The refering 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?In a randomised study the orthodontic space closure will be initiated at two different time intervals. A possible effect will be documented at the primary read out (moment of facilitated space closure) by documentation of the primary end point (reducted number of gingival invagination) and the secondary end point (reduction of the severity of gingival invaginations).