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| Name | Class |
|---|---|
| GuruNanda LLC | INDUSTRY |
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This is a double-blind, randomized, control-arm clinical study to evaluate safety and efficacy of test water flosser in enhancing oral health among healthy adults having plaque-induced gingivitis and dental plaque accumulation.
A total of 64 subjects, including males and non-pregnant, non-lactating females aged between 18 and 65 years (inclusive) with mild to moderate plaque-induced gingivitis will be enrolled to ensure 60 subjects (30 subjects/arm) to complete the study. Subjects will be screened as per the inclusion & exclusion criteria after obtaining written informed consent.
There will be a total of 3 visits during the study. The duration of the study will be 30 Days (±2 Days) from the enrolment.
Visit 01(Day 01): Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage & T30mins Evaluations.
Visit 02 [Day 15 ((±2 Days)]: Test Product Usage Period, Oral Assessments Visit 03[Day 30 (±2 Days)]: Oral Assessments, End of Study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gurunanda - Water Flosser | Experimental | Mode of Usage: Follow the below listed steps for product usage post brushing of teeth.
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| No water Flossing | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gurunanda - Water Flosser | Device | Mode of Usage: Follow the below listed steps for product usage post brushing of teeth.
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| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of the test product in terms of change in plaque deposition | By using Turesky Modification of the Quigley-Hein Index by Dentist or Dentist trained evaluator. | Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days) |
| To assess the effectiveness of the test product in terms of change in plaque induced gingivitis | By using Loe & Silness Gingival Index by Dentist or Dentist trained evaluator. | Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the improvement in product perception questionnaire | Quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation | Baseline prior to usage of test product and on Day 01, Day 15 (±2 days), and Day 30 (±2 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessment by examined of oral soft tissues (tongue, hard and soft palate, gingivae, mucobuccal folds, inner cheeks, sublingual areas) and hard tissues, including dental restorations. | Safety will be assessed by a dentist or dentist-trained evaluator. Findings will be categorized as normal or abnormal and analyzed using an appropriate nonparametric test. | At baseline Day 01 (±2 days), Day 15 (±2 days), and Day 30 (±2 days) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maheshvari N Patel | Contact | 09909013236 | maheshvari@novobliss.in | |
| Sheetal Khandwala | Contact | bd@novobliss.in |
| Name | Affiliation | Role |
|---|---|---|
| Nayan Patel | NovoBliss Research Pvt Ltd | Study Director |
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| No water Flossing | Other | No water Flossing |
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