Clinical and Radiographic Assessment of the Efficacy of a Collagen Membrane in Regenerative Endodontics: A Randomized, Controlled Clinical Trial

Introduction: Recent reviews confirm a general lack of randomized, controlled clinical studies on the efficacy of regenerative endodontics in immature teeth affected by pulp and periapical diseases. Moreover, we have no evidence of the curative efficacy of collagen membranes used as scaffolds in regenerative endodontics. Here, we evaluated whether a Bio-Gide collagen membrane (Geistlich Pharma AG, Wolhusen, Switzerland) has efficacy in promoting dentin formation in regenerative endodontics. Methods: Forty-three patients yielding a total of 46 nonvital immature teeth were divided randomly into 2 groups. Subsequent to chemo-mechanical preparation, regenerative endodontics with (the experimental group) and without (the control group) Bio-Gide were performed. All cases were followed up clinically and radiographically every 3 months for at least 6 months. Quantitative analyses using an imaging program yielded percentage changes in root dimensions based on a comparison between preoperative and recall radiographs. Results: The results of 40 patients (43 teeth) were included in the final analyses. All patients from both groups showed clinical success with complete resolution of signs and symptoms. Radiographically, the thickness of the dentin wall at the middle third of the root was higher for the experimental group than the control group. However, other indicators were comparable between both groups. Conclusions: The use of the Bio-Gide collagen membrane promoted the development of the dentin wall in the middle third of the root in patients undergoing regenerative endodontic procedures. The convenience of operation and the assured positioning of the sealing material make the Bio-Gide collagen membrane especially suitable for handling wide root canals.