💬In plain words
What the trial is, and whether it could suit you
The goal of this study is to scientifically evaluate the efficacy of this oil pulling oral rinse in reducing dental plaque, gingival inflammation, gingival bleeding, and selectively reducing caries- and periodontal disease-associated bacteria compared to a marketed mouthwash and a placebo oral rinse
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
💊
What it tests
- GuruNanda natural Oil Pulling oral rinse
- TheraBreath Plaque Control Oral Rinse
- GuruNanda water-based non-whitening mouthwash
Clinical Research Facility of the Center for Oral Health and Research, UTHSA
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
HealthTeky