Clinical Trial

Assessment of Ozonated Sunflower Seed Oil Gel as an Adjunctive Therapy to Mechanical Debridement in the Treatment of Stage II Grade B Periodontitis

Completed Early Phase 1
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Summary
I) Patients: The present study will be carried on periodontitis patients. The patients will be informed about the treatment steps. This includes the possible effects or risks, and other treatment options according to the rules of the Ethical Committee of Faculty of dentistry, Mansoura University. Groups: Group I (negative control): 15 periodontally healthy subjects. Group II (positive control): 15 patients will be treated with mechanical debridement only. Group III (study group A): 15 patients will be treated with mechanical debridement followed by delivery of sunflower seed oil gel for each pocket. (J MAC BOTANICALS, organic cold pressed helianthus annuus sunflower seed oil, Waterglider LLC. Spokane Valley, WA 99216, USA). Group IV (study group B): 15 patients will be treated with mechanical debridement followed by delivery of ozonated sunflower seed oil gel for each pocket.( PurO3, Ozonated Sunflower Oil combines organic sunflower oil and ozone, giving you an oxygen-rich, soothing gel with high amounts of ozone, 1220 S Happy Hollow Rd Fayetteville, AR 72701, USA). Periodontal evaluation will be performed for all patients at baseline and after three months including the following parameters: * Plaque index (PI).(15) * Gingival index.(16) * Probing pocket depth (PPD).(17) * Clinical attachment level (CAL).(18) B) Gingival crevicular fluid sampling. C) Local drug delivery Adequate amount of prepared ozonated sunflower and sunflower oil gel will be delivered into the selected periodontal pockets. B) Immunological analysis of TNF-α in GCF
Trial Details
NCT Number NCT07636993
Lead Sponsor Mansoura University
Conditions Periodontal Disease, Periodontitis, Periodontitis Stage II
Enrollment 60 participants
Start Date 2025-03-07
Primary Completion 2026-03-25 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-09