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NCT04921371 · ClinicalTrials.gov registry record · Phase 1
Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
A Phase 1 study of Gingivitis and Plaque, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 157
- Enrollment target
- 1
- Study location
NCT04921371: Completed Phase 1 study of Gingivitis and Plaque, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT04921371 is a Phase 1 study of Gingivitis and Plaque that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 157 participants, below the 230-participant average among 25 other Gingivitis trials with a reported enrollment target (32% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04921371, a Phase 1 study of Gingivitis and Plaque, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 157 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage period.
Primary Outcome
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal \[absence of inflammation\]), 1 (Mild inflammation \[slight change in color, little change in texture\] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation \[moderate glazing, redness, edema, and/or hypertrophy\] of the gingival unit); 4 (Severe inflammation \[marked re
Conditions Studied
Interventions
- OTHER Colgate® Cavity Protection Toothpaste
- OTHER Listerine® Cool Mint®
- OTHER Concept Curve Winter Series Toothbrush
- OTHER 5% Hydroalcohol Mouthrinse
- OTHER Mouthrinse Prototype 1
Study Locations (1)
Indiana
- Salus Research, Inc. - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2019-10-08 |
| Est. Completion | 2019-12-19 |
| Phase | Phase 1 |
What the finished NCT04921371 record still lists
NCT04921371 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 230-participant average among 25 other Gingivitis trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Gingivitis appearing as the primary indexed condition, and to 5 interventions - of which Colgate® Cavity Protection Toothpaste is the first listed.
NCT04921371 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT04921371 about?
NCT04921371 is a clinical study titled "Six Week Study of Experimental Mouth Rinses: Effect on Gingivitis and Plaque". The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product u...
What is the current status of trial NCT04921371?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 157 participants. The study started on 2019-10-08. Estimated completion is 2019-12-19.
What conditions does trial NCT04921371 study?
This clinical trial studies the following conditions: Gingivitis, Plaque.
What interventions are being tested in trial NCT04921371?
The interventions under investigation include: Colgate® Cavity Protection Toothpaste (OTHER), Listerine® Cool Mint® (OTHER), Concept Curve Winter Series Toothbrush (OTHER), 5% Hydroalcohol Mouthrinse (OTHER), Mouthrinse Prototype 1 (OTHER).
Who is sponsoring clinical trial NCT04921371?
This trial is sponsored by Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04921371 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gingivitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04921371's enrollment target sits among peer trials
157 7th of 25 higher than 19 of 25 other Gingivitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gingivitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Evaluating Gingivitis and Systemic Biomarkers
ACTIVE NOT RECRUITING · Phase 1
-
Imaging-based Assessment of Oral Biofilm and Gingival Health
RECRUITING · NA
-
Extending Dental Care to Nursing Home Residents to Reduce Mouth Infections and Incidence of Pneumonia and Improve Diabetic Glucose Control
RECRUITING · NA
-
A Clinical Study to Evaluate the Effectiveness of an Experimental Toothpaste in Improving Gum Health and Reducing Plaque Accumulation
RECRUITING · NA
-
Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery
RECRUITING · NA
-
Variation in Gingival Inflammatory Responses
RECRUITING · NA
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