Evaluation of Mangosteen Gel as an Adjunct to One Stage Full-mouth Disinfection in Stage II Periodontitis Patients: A Research Protocol of Randomised Controlled Clinical Trial

Introduction: Periodontitis is a long-term inflammatory disease that deteriorates the tissues supporting teeth. A new staging and grading system helps improve understanding and management of its severity and progression. Stage II periodontitis is characterised by moderate Clinical Attachment Loss (CAL) and Probing Depths (PD) with horizontal bone loss. One Stage Full-Mouth Disinfection (FMD), using agents like Chlorhexidine (CHX), aims to eliminate intraoral reservoirs of pathogens and improve periodontal outcomes. Recent interest has emerged in natural adjuncts such as Garcinia mangostana (mangosteen), known for its antioxidant and anti-inflammatory properties, for their potential role in periodontal therapy. Need of the study: Although FMD has shown benefits over conventional therapy, the adjunctive use of herbal agents like mangosteen gel remains underexplored. Considering the reduced antioxidant capacity observed in periodontitis patients, investigating a potent natural antioxidant like mangosteen as an adjunct to one stage FMD could improve clinical outcomes. Aim: To evaluate the effectiveness of mangosteen gel in onestage FMD treatment of Stage II periodontitis patients, focusing on improvements in PD, CAL and Bleeding On Probing (BOP). Methods and Materials: This randomised controlled parallel arm clinical trial will involve 30 systemically healthy individuals diagnosed with Stage II periodontitis, recruited from the outpatient Department of Periodontics at Sharad Pawar Dental College, Sawangi (Meghe), Wardha. The study proposal (ref. no. DMIHER(DU)/IEC/2024/51) has been approved by the DMIHER Institutional Ethical Committee (IEC). The patients will be randomly divided into two groups and the planned overall duration of the study will be one year from December 2024 to November 2025, while it will include a follow-up period of six months. Group-A will receive one-stage FMD, performed within 24 hours and consisting of subgingival Scaling and Root Planing (SRP) with adjunctive measures described in the original FMD protocol by Quirynen M et al., including CHX mouth rinse, tongue brushing, and pocket irrigation. Group-B will undergo the same FMD regimen as Group-A, with the addition of subgingival application of mangosteen gel in all periodontal pockets one week postoperatively. Since CHX is an integral component of the established FMD protocol, the present study specifically evaluates the adjunctive effect of mangosteen gel beyond this standard regimen. Clinical data, including the Probing Pocket Depth (PPD), CAL, BOP will be recorded at baseline, three months, and six months. To determine the importance of variations within and across groups, the data will be analysed using appropriate statistical methods, including the Wilcoxon signed-rank test. Using IBM SPSS Statistics, SPSS v17 statistically significant p-value is defined as being less than 0.05.