Evaluation of the Effectiveness of Injectable Platelet-Rich Fibrin as an Adjuvant to One-Stage Full-Mouth Disinfection in Patients with Stage II and III Periodontitis: Protocol for a Randomized Clinical Trial.

Background: Periodontitis is a chronic inflammatory disease that leads to the progressive destruction of the tooth-supporting structures, including the periodontal ligament, alveolar bone, and gingival tissues, leading to tooth mobility, ultimately resulting in potential tooth loss if left untreated. The new classification of periodontitis helps in establishing an appropriate diagnosis and planning treatment according to disease severity. One-stage full-mouth disinfection (OS-FMD), using chlorhexidine, has shown better outcomes than traditional quadrant-wise therapy. Platelet-Rich Fibrin offers enhancement in healing outcomes and regeneration due to sustained release of growth factors. Injectable platelet-rich fibrin (i-PRF) shows promising results in promoting tissue regeneration, reducing inflammation, and improving periodontal therapy outcomes. To date, no clinical study has been carried out for the assessment of the efficacy of i-PRF as an adjuvant in OS-FMD. Objective: This study aims to assess the efficacy of i-PRF as an adjuvant in OS-FMD therapy based on its clinical outcomes in terms of plaque index (PI), papillary bleeding index (PBI), probing depth (PD), and clinical attachment loss (CAL) in patients with stage II and stage III periodontitis. Methods: This randomized clinical trial will include 26 systemically healthy patients diagnosed with stage II and III periodontitis, selected from the Outpatient Department of Periodontics at Sharad Pawar Dental College, Sawangi (Meghe), Wardha. Participants will be randomly assigned to one of 2 groups using a parallel-arm design to ensure unbiased allocation. The control group will undergo OS-FMD therapy involving subgingival scaling and root planing for the entire dentition, which will be performed within 24 hours, supplemented by application of chlorhexidine intraorally, including mouth rinsing, pocket irrigation, and tongue cleansing. The test group will receive the same OS-FMD protocol as the control group, in addition to subgingival delivery of i-PRF in all periodontal pockets 1 week post therapy. Assessment of clinical parameters, including PI, PBI, PD, and CAL, will be done at baseline, 3 months, and 6 months. To evaluate intragroup and intergroup differences, statistical analysis will be conducted using appropriate methods, including the Wilcoxon signed-rank test. A P value <.05 will be considered statistically significant. Results: The study was enrolled in June 2025 and is scheduled to conclude post assessments and analyses by the end of 2026. The accessibility of the study results is anticipated in early 2027. Conclusions: This study underscores the effectiveness of i-PRF as an adjuvant in OS-FMD therapy on the basis of assessment of clinical parameters. We hypothesize that the use of i-PRF as an adjuvant to OS-FMD will result in superior clinical outcomes beyond the antimicrobial benefits achieved with chlorhexidine in standard OS-FMD, as evidenced by CAL gain, reduction in PD, and reduction in the scores of PI and PBI, due to regenerative and anti-inflammatory properties of i-PRF along with enhanced healing potential.