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

接受抗骨吸收治疗的高危患者拔牙后不同塑料伤口闭合技术的比较——随机、对照、盲法、可行性试验

• 批准号: 318789385
• 负责人: Privatdozent Dr. Oliver Ristow
• 金额: --
• 依托单位: Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2017-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/318789385?language=en
• 关键词: Comparison; different; plastic; wound; closure

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.

本研究大纲是为早期职业研究人员举办的第二期DFG讲习班的一部分。这项研究是一项多中心、随机、对照、双盲的临床可行性试验，有两个平行的研究臂，旨在证明在接受抗吸收治疗的患者中，在术后伤口裂开和药物相关性颌骨坏死的发生率方面，骨膜下皮瓣提高术用于塑料伤口闭合优于骨膜上皮瓣提高术。基本假设是，与骨膜下技术相比，采用骨膜外技术的患者在拔牙时裂开的发生率和与药物相关的颌骨坏死的发生率更高。主要疗效终点被定义为术后8周发生与药物有关的颌骨骨坏死。评估了几个次要终点，包括黏膜完整性的丧失，检测到与药物有关的颌骨早期病变(使用荧光技术和组织病理学检查)，与药物有关的颌骨早期病变的放射征象，以及参与者的健康相关生活质量，由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个月内和6个月的随访期间招募40名患者。这项初步研究的结果将用于第三阶段验证性试验的功率计算，目的是产生可用于未来预防药物相关的颌骨坏死治疗指南的循证数据。