Pilot Study on early space closure to prevent gingival invaginations

在一项回顾性研究中，拔牙后直到开始正畸间隙关闭的时间因素被确定为牙龈内陷发展的潜在危险因素。这项初步研究的目的是证明这一假设，并为进一步的临床试验提供病例量计算。问题是：拔牙后尽早进行正畸间隙封闭，是否可以减少牙龈内陷的发生？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（减少牙龈内陷的次数）和次要终点（减少牙龈内陷的严重程度），在主要读数（促进空间关闭的时刻）记录可能的效果。

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).