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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovoBliss Research Pvt Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Gurunanda - Water Flosser
  • No water Flossing

Treatment groups

64 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators