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

本研究大纲是作为早期职业调查人员第二次DFG研讨会的一部分开发的。本研究提供了一项多中心、随机、对照、设盲、临床可行性试验，包括两个平行研究组，以证明在接受抗吸收治疗的患者中，拔牙后，在术后伤口裂开和药物相关颌骨骨坏死的发生率方面，骨膜下瓣提升用于塑料伤口闭合上级优于骨膜瓣提升用于塑料伤口闭合。主要假设是，与骨膜下技术相比，采用骨膜上技术治疗的患者在拔牙患者中的裂开率和药物相关颌骨骨坏死的发生率具有临床相关性。主要疗效终点定义为术后8周发生药物相关颌骨骨坏死。评价了几个次要终点，包括粘膜完整性丧失、药物相关颌骨骨坏死早期病变的检测（使用荧光技术和组织病理学检查）、药物相关颌骨骨坏死早期病变的放射学体征（作为威尔斯的受试者健康相关生活质量，通过EQ-5D（健康结局的标准化测量）测量）。整个试验计划为期12个月，6个月内招募40名患者，并进行6个月的随访。本初步研究的结果将用于验证性III期试验的把握度计算，目的是产生可用于未来预防性药物相关颌骨骨坏死治疗指南的循证数据。

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.