Clinical Trial

Effectiveness of Coconut Oil Pulling With Clove Oil, Coconut Oil Pulling and Fluoride Mouthwash on Streptococcus Mutans Count in Children

Study acronym: COPCO
Not Yet Recruiting
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Record status
This record was last updated April 4, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
This study aims to compare the effectiveness of coconut oil pulling with clove oil, coconut oil pulling alone, and fluoride mouthwash in reducing Streptococcus mutans levels in children aged 6-12 years. Participants will be randomly assigned to one of three groups: 1. Coconut Oil Pulling with Clove Oil Group - Daily swishing with coconut oil mixed with clove oil. 2. Coconut Oil Pulling Group - Daily swishing with coconut oil alone. 3. Fluoride Mouthwash Group (Control) - Using fluoride mouthwash as per standard guidelines. The primary outcome is the reduction in Streptococcus mutans count, assessed through microbiological analysis of saliva samples at baseline, immediately after intervention, and after 4 weeks. Secondary outcomes include patient acceptability, adherence, and gingival health. This randomized controlled trial will provide insight into natural alternatives for oral health maintenance in children. Study Location: Cairo University, Faculty of Dentistry. Estimated Study Duration: May 2025 - January 2026.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-24.
Trial Details
NCT Number NCT06902532
Lead Sponsor Cairo University
Conditions Dental Caries
Enrollment 105 participants
Start Date 2025-05-01
Primary Completion 2025-11-01 (estimated)
Study Completion 2026-01-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-04