Comparative Evaluation of Autologous Sticky Bone, Platelet-Rich Fibrin, and Octacalcium Phosphate-Coated Deproteinized Bovine Bone Material for the Regeneration of Human Periodontal Infrabony Defects: Protocol for a Randomized Controlled Clinical Trial.

BACKGROUND: The term periodontium encompasses the supporting structures around a tooth, including gingival tissue, alveolar bone, cementum, and periodontal ligament. Periodontal disorders are highly prevalent, affecting approximately 95% of the Indian population. Restoring the missing attachment apparatus is the main goal of regenerative therapy in cases of periodontal disease. The reproduction or rebuilding of damaged or lost periodontal tissue to restore the structure and functionality of the periodontium is known as regeneration. This study investigates the effectiveness of autologous sticky bone (ASB), autologous platelet-rich fibrin (PRF), and octacalcium phosphate-coated deproteinized bovine bone material (OCP-DBBM). These materials are being evaluated for their potential to enhance bone regeneration in infrabony defects, which are a significant concern in periodontal therapy. Effective bone regeneration is critical for the successful treatment of periodontal defects, as it can lead to improved clinical outcomes, including better attachment levels and reduced probing depths. This study aims to provide insights into the most effective methods for achieving these goals. OBJECTIVE: We aim to assess the efficacy of ASB and autologous PRF in conjunction with OCP-DBBM in infrabony defects at 6 months after surgery with regard to radiographic bone fill, reduction in probing pocket depth, and increase in clinical attachment level. METHODS: This randomized controlled clinical trial will be performed on 20 defects in patients diagnosed with stage 2 and 3 grade B periodontitis. It will be a parallel-designed study where group 1 (n=10) will be treated with ASB and group 2 (n=10) will be treated with autologous PRF and OCP-DBBM. One sitting will be required to perform the treatment, and a follow-up checkup will be done at 6 months. RESULTS: Recruitment procedures started in June 2025. All data are anticipated to be collected by February 2026. Full trial results are anticipated to be analyzed and submitted for publication by March 2026. The study's anticipated end date is March 2026. CONCLUSIONS: Both treatment approaches are expected to lead to notable gains in periodontal health and bone regeneration. The primary outcome, radiographic bone fill, and the secondary outcomes, clinical attachment level gain and probing pocket depth reduction, are critical indicators of treatment success. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2024/06/069603; https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAzODk0&Enc=&userName=. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/69666.