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.
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 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.
Parallel
Gurunanda - Water Flosser
DeviceMode 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
Other interventionNo 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.
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.
To assess the improvement in product perception questionnaire
Quality of life questionnaire through 5-point Likert scale to evaluate the changes in plaque formation
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.
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
GuruNanda LLC
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
