Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-25 @ 9:46 PM
Study NCT ID:
NCT07204951
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-07
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Safety and Efficacy Study of Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-induced Gingivitis and Dental Plaque Accumulation
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Control-Arm Clinical Study to Evaluate the Safety and Efficacy of Test Water Flosser in Enhancing Oral Health Among Healthy Adults Having Plaque-Induced Gingivitis and Dental Plaque Accumulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: