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

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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.