Not Yet RecruitingNot Applicable

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

64 participantsStarted 2025-11-13

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age: 18 to 65 years (both inclusive) old at the time of consent.
✓. Sex: Healthy adult males and non-pregnant/non-lactating females.
✓. Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
✓. Subjects are generally in good general health as determined from recent medical history.
✓. Subjects with mild to moderate gingivitis and good oral health, without hard or soft tissue lesions, with moderate gingivitis characterized by more than 30% bleeding sites and probing depths of ≤3 mm without attachment loss.
✓. Anterior teeth without restorations.
✓. No dental treatments being performed before or during the study period.
✓. Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.

Exclusion criteria

✕. Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
✕. Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
✕. Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
✕. Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
✕. Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
✕. Suffering from untreated dental caries, mucosal lesions, oral tumors or severe systemic diseases that may affect periodontal diseases.
✕. Subjects have any known allergies to over-the-counter oral hygiene/products.
✕. Subjects have any known allergies to the trial product ingredients.

What they're measuring

To assess the effectiveness of the test product in terms of change in plaque deposition

Timeframe: 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

Timeframe: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)

Trial details

NCT IDNCT07204951

SponsorNovoBliss Research Pvt Ltd

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-13

Contact for this trial

Maheshvari N Patel

09909013236 maheshvari@novobliss.in

View on ClinicalTrials.gov More Plaque Induced Gingivitis trials

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age: 18 to 65 years (both inclusive) old at the time of consent.
✓. Sex: Healthy adult males and non-pregnant/non-lactating females.
✓. Females of childbearing potential have a self-reported negative urine pregnancy test at the time of the screening visit and agree to follow an accepted method of birth control for the duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
✓. Subjects are generally in good general health as determined from recent medical history.
✓. Subjects with mild to moderate gingivitis and good oral health, without hard or soft tissue lesions, with moderate gingivitis characterized by more than 30% bleeding sites and probing depths of ≤3 mm without attachment loss.
✓. Anterior teeth without restorations.
✓. No dental treatments being performed before or during the study period.
✓. Possessing at least 20 permanent teeth (excluding the third molars) and 5 evaluable teeth in each quadrant.

Exclusion criteria

✕. Subjects who are undergoing treatment for gingivitis, caries, dental plaque and sensitivity.
✕. Subjects are present with fixed orthodontic appliances on the facial surfaces of the maxillary arch.
✕. Subjects have dental crowns, veneers or composite restorations on gradable maxillary anterior teeth (canine to canine) or mandibular anterior teeth.
✕. Subjects have any oral pathologies or gross neglect of home care requiring prompt treatment, including periodontal disease, as evidenced by purulent exudate, tooth mobility, and/or other signs indicating that the integrity of the data collected for that subject might be compromised.
✕. Subjects are present with any pre-existing oral or medical condition that the Investigator/designee determines may place the subject at increased health risk from study participation.
✕. Suffering from untreated dental caries, mucosal lesions, oral tumors or severe systemic diseases that may affect periodontal diseases.
✕. Subjects have any known allergies to over-the-counter oral hygiene/products.
✕. Subjects have any known allergies to the trial product ingredients.

What they're measuring

To assess the effectiveness of the test product in terms of change in plaque deposition

Timeframe: 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

Timeframe: Before and after usage of test product at T30 mins on Day 01, Day 15 (±2 days), and Day 30 (±2 days)