Health TrialsbyHealthPanel

Oil Pulling Whitening Mouthwash

ConditionsHealthy Adult ParticipantsTooth Stain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorThe University of Texas Health Science Center at San Antonio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult subjects aged 18-60, that are in good health.

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.

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.

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.

Disqualifiers

Pregnant or nursing by subject report.

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).

Any active condition in the oral cavity at the discretion of the investigator.

Any surgery or dental procedure in the treated area within 3 months prior to treatment, or before complete healing.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GuruNanda natural Oil Pulling oral rinse

    Dietary supplement

    Test product

  • Therabreath Whitening Mouthwash - Dazzling Mint

    Dietary supplement

    positive control

  • GuruNanda water-based non-whitening mouthwash

    Dietary supplement

    negative control

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Test ProductExperimental treatment 1 intervention
Group B: Positive ControlActive comparator 1 intervention
Group C: Negative ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Measurement by the VITA Easyshade Advance 4.0

A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade

Time frame
Baseline to 8 weeks
2

VITA Bleachguide 3-D Master Shade Guide

A single examiner will perform visual tooth shade assessment under standard lighting conditions. Tooth shade will be scored on selected anterior teeth . The tab marking system includes interpolated shade guide units (sgu) ranging from 1 to 29 sgu with a lower score indicating more whitening. Subject shade rank scores will be determined for each visit by calculating the mean value across the selected anterior teeth scored.

Time frame
Baseline to 8 weeks
3

Lobene Stain Index

Measure of intensity and extent of extrinsic stain on the facial surfaces of 12 anterior teeth. The teeth are divided into regions which are scored separately. Intensity is scored from 0 (no stain) to 3 (heavy stain; dark brown to black) and extent is scored from 0 (no stain) to 3 (stain covering over two-thirds of the region). Scores will be averaged for each subject for intensity (sum of all intensity scores/all sites graded) and extent (sum of all extent scores/all sites graded), and the composite stain score calculated by multiplying the mean stain intensity by the mean stain extent.

Time frame
Baseline to 8 weeks

Secondary outcomes

1

Satisfaction: Subjective participant questionnaires

Front teeth appearance: Five subjects will be selected from each study group for this purpose. A digital imaging system, camera (Canon EOS 50D), will be used. The camera (Canon EOS 50D) is to be attached to a standardized head positioner to allow for consistency between images. A digital exposure will be made with include lips/cheeks retracted and anterior teeth aligned edge to edge. Another digital exposure will also be made with the subjects smiling but covering just the area between nose and chin. Photographs will be taken as digital images before the treatment and at the final study visit when efficacy assessments are completed. Lighting conditions will be as described for the tooth shade assessments to ensure uniformity among subjects and consistency across time.

Time frame
8 weeks
2

Satisfaction Questionnaire

A questionnaire containing 6 scorable items with a potential score of (a) 5=Very High to (e)1=Very Low and 4 free response questions. Total scores range from 6-30 with a higher score indicating greater satisfaction

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center at San Antonio

Lead sponsor

GuruNanda LLC

Collaborator

Source ClinicalTrials.gov
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