💬In plain words
What the trial is, and whether it could suit you
The goal of this study is to evaluate the tooth whitening efficacy of Oil Pulling oral rinse compared to a competitor's whitening mouthwash and a water-based mouthwash (placebo). Each participant will use one of three mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). All mouthwashes will be used once daily last thing before bed at night. Data will be collected on tooth shade evaluated on the anterior teeth.
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 18-60, that are in good health.
2. Subject must have at least 2 natural anterior teeth, each having a mean Lobene composite score of ≥ 1.5 on the facial surfaces as assessed by the Investigator.
3. Subject's front teeth shade should be 9 or darker (meaning shade score should be between 9 and 29), as assessed by the Vita bleachguide 3D-Master and the Vita EasyShade device.
4. 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.
5. The subjects should be willing to comply with the study procedure and schedule, including the follow up visits, and will refrain from using any other teeth whitening technologies during this period.
6. The subject did not perform any procedure for teeth whitening (either at home or in clinic) at least 3 years prior to participating in the study.
Exclusion Criteria:
1. Pregnant or nursing by subject report.
2. Known allergic reaction to any of the study mouthwashes or any of their components. Participant has completed the screening questionnaire (Exclusion due to Known Allergens).
3. Any active condition in the oral cavity at the discretion of the investigator.
4. Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.
5. Subjects that do not brush regularly.
6. Any condition that might make it unsafe for the subject to participate in the study, at the discretion of the investigator.
7. Heavy tobacco use, including cigarettes, cigars, or smokeless tobacco.
8. Consumption of stain-causing substances (e.g., red wine, coffee, tea) that cannot be avoided during the study period.
9. Use of medications that may affect tooth discoloration (e.g., tetracyclines, chlorhexidine).
10. Participation in another clinical trial within the last 30 days.
11. Presence of orthodontic appliances, except for removable retainers.
12. Signs of advanced enamel wear, dentin exposure, or tooth fractures.
HealthTeky