Clinical Research Directory

Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis

Sponsor: Bahria University

Summary

The goal of this clinical trial is to learn if daily oil pulling with coconut oil or sesame oil works as effectively as a standard mouthwash to treat gum swelling and redness (gingivitis) in adults aged 18 to 55 years. The main questions it aims to answer are: * Does daily oil pulling with virgin coconut oil or sesame oil reduce dental plaque buildup as effectively as 0.2% chlorhexidine mouthwash over an 8-week period? * Does oil pulling reduce gum inflammation, bleeding, and tongue coating while avoiding common mouthwash side effects such as tooth staining? * Does oil pulling improve oral health-related quality of life and overall patient satisfaction? Researchers will compare three groups - participants using coconut oil, participants using sesame oil, and participants using 0.2% chlorhexidine mouthwash - to evaluate changes in oral health over 8 weeks. Participants will: * Receive professional dental cleaning (scaling) and standardized toothbrushing instructions at the start of the study. * Swish 10 mL of their assigned oil for 7 minutes once daily in the morning on an empty stomach, or rinse with 10 mL of 0.2% chlorhexidine mouthwash for 1 minute at night, every day for 8 weeks (56 days). * Visit the dental clinic at baseline (Day 0), week 4 (Day 28), and week 8 (Day 56) for clinical oral exams, salivary pH testing, and short surveys on comfort and satisfaction. 2\. Clinical Trial Registry (CTR) Protocol Registration Fields Registry Field Name Protocol Value / Description Official Title Effectiveness of Oil Pulling Using Oils in Comparison with Mouthwash for Gingivitis: A Single-Blind Randomized Control Trial Brief Title Effectiveness of Oil Pulling vs. Chlorhexidine Mouthwash for Gingivitis Study Type Interventional (Clinical Trial) Primary Purpose Treatment Allocation Randomized (1:1:1 ratio across 3 parallel arms) Intervention Model Parallel Assignment Masking Single Blind (Outcome Assessor blinded) Target Enrollment 45 participants (15 per arm, adjusted for 20% dropout) Condition / Disease Gingivitis / Plaque-Induced Gingival Inflammation Age Range 18 Years to 55 Years Sex / Gender All (Males and Females) Accepts Healthy Volunteers No (Requires clinically diagnosed plaque-induced gingivitis) Inclusion Criteria Clinically diagnosed gingivitis; Community Periodontal Index of Treatment Needs (CPITN) Grade 1 or 2; presence of at least 10 natural teeth. Exclusion Criteria CPITN Grade 0, 3, or 4; chronic illnesses (diabetes, hypertension, cardiovascular, renal/hepatic dysfunction); pregnancy/lactation; tobacco/smokeless tobacco users; recent antibiotics, antimicrobial mouthwashes, or scaling within last 3 months; known allergy to sesame oil, coconut oil, or chlorhexidine. Experimental Arm 1 (Coconut Oil) 10 mL coconut oil swished/pulled once daily in the morning on an empty stomach for 7 minutes for 56 days. Experimental Arm 2 (Sesame Oil) 10 mL sesame oil swished/pulled once daily in the morning on an empty stomach for 7 minutes for 56 days. Active Comparator Arm (0.2% Chlorhexidine) 10 mL 0.2% chlorhexidine digluconate mouthwash rinsed for 1 minute once daily at night after brushing for 56 days. Primary Outcome Measure Change in Silness and Loe Plaque Index (PI) at Baseline (T1), Day 28 (T2), and Day 56 (T3).

Official title: Effectiveness of Oil Pulling Using Oils in Comparison Mouthwash for Gingivitis

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