Accepted for/Published in: JMIR Research Protocols
Date Submitted: Dec 5, 2024
Date Accepted: Apr 21, 2025
: “A protocol study for Comparative Evaluation of the Effectiveness of Autologous Sticky Bone with that of Autologous PRF and Octacalcium Phosphate-Coated Deproteinized Bovine Bone Material in the Regeneration of Human Periodontal Infrabony Defects – A Randomized Controlled Clinical Trial.”
ABSTRACT
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 in order to restore the periodontium's structure and functionality is known as regeneration. The study investigates the effectiveness of ASB, autologous platelet-rich fibrin PRF, and octacalcium phosphate-coated deproteinized bovine bone material. These materials are being evaluated for their potential to enhance bone regeneration in infrabony defects, which is 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. The study aims to provide insights into the most effective methods for achieving these goals.
Objective:
To assess the efficacy of ASB and autologous PRF in conjunction with octacalcium phosphate coated deproteinized bovine bone material in infrabony defects at 6 months post-surgery with regard to radiographic bone fill, reduction in probing pocket depth (PPD), and increase in clinical attachment level (CAL).
Methods:
This randomized controlled clinical trial will be performed on 20 defects in patients diagnosed with chronic periodontitis. It will be a parallel designed study where Group 1(n=10) will be treated by ASB and Group 2 n=10 will be treated by Autologous PRF + “Octacalcium Phosphate Coated Deproteinized Bovine Bone Material”. One sitting will be required to perform the treatment and the follow up will be done at 6 months.
Results:
The primary outcome of "radiographic Bone Fill" and secondary outcomes of "Clinical Attachment Level gain" and "Probing Pocket Depth Reduction" are critical indicators of treatment success.
Conclusions:
According to the study, both treatment approaches are expected to show notable gains in periodontal health and bone regeneration. Clinical Trial: The approval for this study is given by the “Institutional Ethics Committee” of DMIHER (DU) under process number “DMIHER DU /IEC/2024/227”. The findings will be presented at conferences and published in peer-reviewed journals. “Trial registration number for CTRI: CTRI/2024/06/069603 [Registered on: 27/06/2024] URL for CTRI: https://ctri.nic.in/Clinicaltrials/rmaindet.php?trialid=103894&EncHid=53849.75918&modid=1&compid=19
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