Healthy Adult Participants, Tooth Stain
Conditions
Keywords
tooth whitening, tooth stains, oil pulling, mouthwash, mouth rinse, stain removal
Brief summary
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.
Detailed description
A total of 120 subjects who met all necessary requirements for selection as subjects will be stratified into three balanced groups (40 per group) according to age, gender, and their mean baseline tooth shade measured using the VITA Easy Shade Advance Spectrophotometer. Males and females aged between 18 and 60 years will be enrolled. The three groups will be randomly assigned to use one of three test mouthwashes: GuruNanda Oil Pulling oral rinse (test), Competitor's mouthwash (positive), Water-based oral rinse (placebo). Subjects will be instructed to use their assigned mouthwash as an adjunct oral hygiene product for the 8-week treatment duration. All subjects will be provided with the same brand of toothpaste (non-antimicrobial) and a soft-bristled toothbrush to use for their routine daily toothbrushing for the 8-week treatment duration. All study products will be used according to their manufacturers' instructions. However, to facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects. All mouthwash will be used once daily before bed at night, while toothbrushing will be performed twice daily in the morning and before bed at night. For each test subject, assessment data will be collected at baseline, 4 weeks, and 8 weeks. Data will be collected on tooth shade evaluated using the Lobene Stain Index, VITA Bleachedguide 3D-Master shade guide and the Vita EasyShade® Advance 4.0 Spectrophotometer on the anterior teeth. The average summary scores will be calculated for each group on each of these measurements. All dental examinations for data collection in all 120 subjects will be conducted by the same Clinical Examiner throughout the study. Subjects will be examined and queried on adverse events at each study visit.
Interventions
DIETARY_SUPPLEMENTGuruNanda natural Oil Pulling oral rinse
Test product
DIETARY_SUPPLEMENTTherabreath Whitening Mouthwash - Dazzling Mint
positive control
DIETARY_SUPPLEMENTGuruNanda water-based non-whitening mouthwash
negative control
Sponsors
The University of Texas Health Science Center at San Antonio
GuruNanda LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
To facilitate double blinding, only the Randomizer will dispense the products, give instructions on the use of the products, and supervise the first use of the product at the clinical facility. The clinical Examiner and other study team members will not discuss product-use with the subjects.
Intervention model description
This is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group prospective clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement by the VITA Easyshade Advance 4.0 | Baseline to 8 weeks | A probe tip is placed on an area of the enamel surface that has underlying dentin and a measurement made of the shade |
| VITA Bleachguide 3-D Master Shade Guide | Baseline to 8 weeks | 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. |
| Lobene Stain Index | Baseline to 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction: Subjective participant questionnaires | 8 weeks | 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. |
| Satisfaction Questionnaire | 8 weeks | 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 |
Countries
United States
Contacts
CONTACTBennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI
CONTACTRazina Vohra
Outcome results
None listed