NCT07204951

Clinical Safety and Efficacy Study of Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-induced Gingivitis and Dental Plaque Accumulation

A Double-Blind, Randomized, Control-Arm Clinical Study to Evaluate the Safety and Efficacy of Test Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-Induced Gingivitis and Dental Plaque Accumulation

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Plaque Induced Gingivitis

Interventions

Type	Name	Description
DEVICE	Gurunanda - Water Flosser	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.
OTHER	No water Flossing	No water Flossing

Timeline

• Start date: 2025-11-13
• Primary completion: 2025-11-13
• Completion: 2025-12-06
• First posted: 2025-10-03
• Last updated: 2025-11-10

Regulatory

• FDA-regulated device study