Clinical Safety and Efficacy Study of Water Flosser in Enhancing Oral Health Among Healthy Adults… (NCT07204951) | Clinical Trial Compass
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 range
18 Years – 65 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)
. 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.