Oil Pulling Mouthwash Reduction in Plaque and Inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, blinded study enrolls 120 adults aged 18-70 with gingival inflammation and plaque, assigning them equally to three mouthwashes for 8 weeks. Participants will use the assigned rinse once nightly while brushing habits remain the same, with baseline, 4-week, and 8-week assessments of gingival inflammation, gingival bleeding, and plaque. Examiners and staff will remain blinded to group assignments to minimize bias. Data will compare changes in gingival health and plaque across the oil pulling rinse, the competitor rinse, and the placebo water rinse.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult subjects aged 18-70, that are in good health.
2. Subject must have:

   1. Baseline gingival inflammation (MGI) score of at least 1.80.
   2. Baseline gingival bleeding (GBI) score of ≥ 1 on at least 20 sites.
3. An overnight (12 to 18 hour abstention from any oral hygiene) dental plaque (mean) score greater than 0.6 according to the RMNPI Index.
4. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
5. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects. Subjects will sign the Informed Consent Form.
6. The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits.

Exclusion Criteria:

1. Current or history of oral cavity cancer or oropharyngeal cancer.
2. Subject with destructive periodontal disease or those on antibiotic or anti-inflammatory drugs.
3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
4. Pregnant or nursing by subject report.
5. Known allergic reaction to any of the study mouthwashes or any of their component.
6. Any active condition, including but not limited to advanced periodontal disease or severe gingival recession, in the oral cavity at the discretion of the investigator.
7. Any surgery or recent dental procedure in the oral cavity within 3 months prior to treatment, or before complete healing.
8. Subjects that do not brush regularly.
9. Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
10. History of allergy or hypersensitivity to mouthwash ingredients
11. Significant medical conditions, such as uncontrolled diabetes or immunosuppressive disorders
12. Use of tobacco products, including cigarettes and smokeless tobacco
13. Presence of orthodontic appliances, except for removable retainers
14. Participation in another clinical trial within the last 30 days.
15. Individuals unable to comply with study requirements, such as regular product use or scheduled visits.
16. Habitual use of alcohol or drugs that may affect compliance or oral health

Where it's running

• Clinical Research Facility of the Center for Oral Health and Research, UTHSA
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Bennett T Amaechi, BDS, MS, PhD
• Email: amaechi@uthscsa.edu
• Phone: 210-567-3185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.