Oil Pulling Mouthwash for whitening teeth in adults

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 compares three mouthwashes over 8 weeks: GuruNanda Oil Pulling oral rinse (test), a commercially available whitening mouthwash (positive), and a water-based rinse (placebo). Participants aged 18–60 with certain tooth shade criteria are stratified by age, gender, and baseline shade, then assigned to one of the three arms and instructed to use the assigned rinse once nightly as an adjunct to standard oral care. Tooth shade will be measured at baseline, 4 weeks, and 8 weeks using standardized spectrophotometric methods. The trial aims to determine if the oil-pulling rinse can achieve whitening effects comparable to or better than the whitening mouthwash without additional interventions.

Why it matters

Who can join: the full rules

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.

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, MFDS RCPS, FADI
• 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.