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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
64
Mode of Usage: Follow the below listed steps for product usage post brushing of teeth. 1. Fill - Add water to the tank of the Flosser 2. Insert - Add the tip to the flosser 3. Select - Choose the level of pressure 4. Floss - Guide the stream between your teeth and along the gumline 5. Clean - After use, insert the tip in the water tank and sanitize Frequency: Use twice a day after brushing. Route of administration: Topical - Oral Storage Condition: Store in a cool, dry place, away from direct sunlight, and do not submerge in water.
No water Flossing
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.
Time frame: 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.
Time frame: 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 improvement in product perception questionnaire
Quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation
Time frame: Baseline prior to usage of test product and on Day 01, Day 15 (±2 days), and Day 30 (±2 days)
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