NCT06327841CompletedNot Applicable
The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study
Medical University Innsbruck2 sites in 1 country40 target enrollmentStarted: June 21, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Rustogi Modified Navy Plaque Index (RMNPI)
Study Overview
Brief Summary
The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:
• is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.
Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age ≥ 18 years
- •contractual capability
- •the presence of ≥ 10 teeth,
- •community periodontal index of treatment needs (CPITN) grade 1 or 2
Exclusion Criteria
- •missing consent
- •community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
- •pregnancy or breastfeeding
- •systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
- •mental and behavioral disorders that impede (verbal) communication
- •allergy against sesame(oil)
- •intake of antibiotics 6 months prior to or during study duration
- •intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
- •infectious diseases (e.g. HIV, hepatitis B or C)
- •fixed orthodontic appliances
- •ongoing oil pulling or mouth rinsing
- •adult guardianship
- •insufficient nasal breathing
Outcomes
Primary Outcomes
Rustogi Modified Navy Plaque Index (RMNPI)
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
Secondary Outcomes
- Gingival Index (GI)(first follow up after 4 weeks, full study duration 8 weeks)
- Oral Health Impact Profile (OHIP)(first follow up after 4 weeks, full study duration 8 weeks)
- microbial analysis(first follow up after 4 weeks, full study duration 8 weeks)
- Interview halitosis, xerostomia(first follow up after 4 weeks, full study duration 8 weeks)
Investigators
Christine Zürcher
Dr.med.dent.
Medical University Innsbruck
Study Sites (2)
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