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Clinical study on dental floss in gum swelling and teeth health

Evaluation of efficacy and safety of Compact Dental Water Flosser in gingival and teeth health A Prospective randomized, open label, blinded end point assessor (PROBE) clinical study. - NIL

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095187
Enrollment
60
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K050- Acute gingivitis

Interventions

Intervention1: Toothbrush with an ADA Accepted Fluoride dentifrice with additional use of the water flosser: Participant will be asked to use toothbrush with an ADA Accepted Fluoride dentifrice twice

Sponsors

GuruNanda LLC
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Participants without loss of interproximal clinical periodontal attachment, with papilla completely filling the interproximal space, and with at least 24 teeth 2.Qualified participants should present with Gingival Index score 2 and more than 15 percent of the interproximal sites, excluding posterior distal sites excluded. 3.Willing to comply with all requirements of the study including post treatment care and attending all treatment and follow up visits.

Exclusion criteria

Exclusion criteria: 1.Vulnerable population, impacting the study outcomes 2.Participants with xerostomia, orthodontic appliances, requiring antimicrobial prophylaxis 3. Known cases of diabetics, smokers. known psychomotor disorders 4. Participants having used antibiotics/anti-inflammatory agents within the last 1 month 5. Known hypersensitivity high pressure dental cleaning as per the investigator 6. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study

Design outcomes

Primary

MeasureTime frame
Change in severity of GingivitisTimepoint: Day 0, Day 15 and Day 30

Secondary

MeasureTime frame
1. Change in dental plaque 2. Change in oral health 3. Assessment of teeth and gingival tissue 4. Global assessment of overall change by the investigator and Participant 5. Assessment of adverse events and adverse drug reactions including vitals Timepoint: Day 0, Day 15 and Day 30

Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026