Assessment of Ozonated Sunflower Seed Oil Gel as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Periodontitis: A Randomized Clinical Trial

Abstract

Objective: To evaluate the clinical and biochemical effects of local drug delivery (LDD)  of ozonated sunflower seed oil formulations as adjuncts to mechanical debridement in patients with stage II periodontitis.Materials and methods: In this randomized controlled clinical trial, 75 participants were allocated into five equal groups (n=15): healthy negative control, positive control treated with mechanical debridement only, or combined with LDD of non-ozonated sunflower formulation (S.F.), prepared ozonated sunflower formulation (O3.S.F.), and Ozoral gel. Full-mouth plaque score (FMPS), bleeding on probing (BoP), probing depth (PD), clinical attachment level (CAL), gingival index (GI), and gingival crevicular fluid TNF-α were assessed at baseline  and after three months. Statistical significance was set at p ≤ 0.05.Results: Age and sex were comparable among the five groups. At baseline, the four periodontitis groups were comparable for all clinical periodontal outcomes and TNF-α. After three months, O3.S.F. showed the lowest FMPS and BoP, Ozoral gel showed the lowest residual PD, and S.F. showed the lowest TNF-α level. Significant intergroup differences were detected for FMPS, BoP, PD, CAL, and TNF-α, but not GI.Conclusion: Locally delivered sunflower-based formulations enhanced selected clinical outcomes when used as adjuncts to mechanical debridement. The prepared ozonated formulation produced the most favourable plaque and bleeding response, whereas Ozoral gel produced  the lowest residual pocket depth.