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| Name | Class |
|---|---|
| GuruNanda LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Product | Experimental |
| |
| Positive Control | Active Comparator |
| |
| Negative Control | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GuruNanda natural Oil Pulling oral rinse | Dietary Supplement | Test product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| 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. | Baseline to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bennett T Amaechi, BDS, MS, PhD, MFDS RCPS, FADI | Contact | 210-567-3185 | amaechi@uthscsa.edu | |
| Razina Vohra | Contact | 210-643-9803 | vohrar@uthscsa.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Facility of the Center for Oral Health and Research, UTHSA | Recruiting | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| D014075 | Tooth Discoloration |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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This is a double-blind, randomized, placebo-and positive-controlled, stratified parallel group prospective clinical trial.
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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.
| Therabreath Whitening Mouthwash - Dazzling Mint |
| Dietary Supplement |
positive control |
|
| GuruNanda water-based non-whitening mouthwash | Dietary Supplement | negative control |
|
| 8 weeks |
| 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 | 8 weeks |