Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT07204951
Brief 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.
Detailed Description:
A total of 64 subjects, including males and non-pregnant, non-lactating females aged between 18 and 65 years (inclusive) with mild to moderate plaque-induced gingivitis will be enrolled to ensure 60 subjects (30 subjects/arm) to complete the study. Subjects will be screened as per the inclusion \& exclusion criteria after obtaining written informed consent.
There will be a total of 3 visits during the study. The duration of the study will be 30 Days (±2 Days) from the enrolment.
Visit 01(Day 01): Screening, ICD obtained, Enrolment, Baseline Evaluation, Product Usage \& T30mins Evaluations.
Visit 02 \[Day 15 ((±2 Days)\]: Test Product Usage Period, Oral Assessments Visit 03\[Day 30 (±2 Days)\]: Oral Assessments, End of Study.
Study:
NCT07204951
Study Brief:
Protocol Section:
NCT07204951