Treating periodontal intrabony defects using guided tissue regeneration and Bio-Oss® with platelet-rich fibrin: study protocol for a self-controlled trial

Abstract

Background and objective: Guided tissue regeneration (GTR) has been widely used for periodontal regeneration after intrabony defects, and Bio-Oss® can be used together with GTR for the stability of the space under the GTR membrane. Platelet-rich fibrin (PRF), as a kind of platelet concentrate with rich autologous biologic agent, has been also used to treat periodontal intrabony defects for periodontal regeneration. However, whether PRF can enhance the regenerative effect of GTR and Bio-Oss® is not reported. Subjects and methods: This is a randomized self-controlled trial. Fourteen patients with periodontal intrabony defects who will receive treatment in the Department of Periodontology, Peking University School and Hospital of Stomatology, China will be included in this study. The left or right intrabony defects of each patient will be randomly randomized to a test group and a control group. In the test group, GTR, Bio-Oss® and PRF will be used for the treatment of periodontal intrabony defects. In the control group, GTR and Bio-Oss® will be used for the treatment of periodontal intrabony defects. PRF used in the trial will be liquid PRF, which can form Bio-Oss®-PRF mixture with Bio-Oss®, making the use of PRF easier in periodontal surgery. This study was approved by the Ethics Committee of Peking University School and Hospital of Stomatology (PKUSSIRB-201629066) on November 4, 2016. Outcome measures: The primary outcome is clinical attachment level, which will be measured at baseline, as well as 6, 12 and 24 months after surgery. The secondary outcomes include (1) depth of intrabony defect, (2) vertical bone loss, (3) probing depth, (4) bleeding index and (5) time of bone graft filling in the surgery. Radiographic evaluation will be accomplished at baseline and at 12 and 24 months after surgery. Probing depth and bleeding index assessments will be performed at baseline, and at 6, 12 and 24 months after surgery. Discussion: If the regenerative effects of GTR, Bio-Oss®, and PRF in combination are superior to those of GTR combined with Bio-Oss®, then the trial results will provide clinical evidence for the treatment of periodontal intrabony defects. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1900027581. Registered on November 19, 2019.