Comparison of different plastic wound closure techniques after tooth extractions in high risk patients under antiresorptive therapy - a randomised, controlled, blinded, feasibility trail

本研究大纲是作为第二次DFG研讨会的一部分为早期职业研究者制定的。本研究提出了一项多中心、随机、对照、盲法的临床可行性试验，采用两个平行研究臂来证明，在接受抗吸收治疗的患者拔牙后，在伤口开裂和药物相关的颌骨骨坏死发生率方面，骨膜下皮瓣提升修复塑料伤口优于骨膜外皮瓣提升修复塑料伤口。我们的初步假设是，与骨膜下技术相比，骨膜外技术治疗的拔牙患者的颌骨崩裂率和药物相关性骨坏死发生率具有更高的临床相关性。主要疗效终点定义为术后8周药物相关性颌骨骨坏死的发生。评估了几个次要终点，包括粘膜完整性的丧失，早期颌骨病变药物相关骨坏死的检测（使用荧光技术和组织病理学检查），早期颌骨病变药物相关骨坏死的放射学征象以及参与者健康相关的生活质量，通过EQ-5D（健康结果的标准化测量）测量。整个试验计划为期12个月，在6个月内招募40名患者，并进行6个月的随访。这项初步研究的结果将用于验证性III期试验的功率计算，目的是产生基于证据的数据，可用于未来与颌骨骨坏死相关的预防性药物治疗指南。

This study outline was developed as part of the second DFG workshop for early career investigators. This study presents a multicentre, randomised, controlled, blinded, clinical feasibility trial with two parallel study arms to demonstrate that sub-periostal flap elevation for plastic wound closure is superior to the epi-periostal flap elevation for plastic wound closure after tooth extractions in patients receiving antiresorptive therapy with respect to postoperative wound dehiscence and the incidence of the medication related osteonecrosis of the jaw. The primary hypothesis is that the dehiscence rate and the incidence of the medication related osteonecrosis of the jaw in patients undergoing tooth extractions is clinically relevant higher for patients treated with the epi-periostal technique compared the sub-periostal technique. The primary efficacy endpoint is defined as the occurrence of medication related osteonecrosis of the jaw eight weeks after surgery. Several secondary endpoints are evaluated including the loss of mucosal integrity, detection of medication related osteonecrosis of the jaw early lesions (using fluorescence techniques and histopathological workups), radiologic signs for medication related osteonecrosis of the jaw early lesions as wells as participant health related qulity of life, measured by EQ-5D (standardised measure of health outcome). The entire trial is planned for 12 months, with an enrollment of 40 patients within six months and six months of follow up. The results of this preliminary study will be used for the power calculation of a confirmatory phase III trail with the goal to produce evidence based data usable for future preventive medication related osteonecrosis of the jaw treatment guidelines.