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NCT04449952 · ClinicalTrials.gov registry record · Phase 4
A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants
A Phase 4 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 4
- Development phase
- 154
- Enrollment target
NCT04449952: Completed Phase 4 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT04449952 is a Phase 4 study that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 154 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04449952, a Phase 4 study, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 154 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment 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
Interventions
- OTHER Colgate Cavity Protection Toothpaste
- OTHER 5% Hydroalcohol Mouth Rinse
- OTHER Listerine Cool Mint
- OTHER Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula
- DEVICE Concept Curve Winter Series Toothbrush
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2019-12-02 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 4 |
What the finished NCT04449952 record still lists
NCT04449952 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Colgate Cavity Protection Toothpaste is the first listed.
NCT04449952 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04449952 about?
NCT04449952 is a clinical study titled "A Study of Mouth Rinses in Type 1 and Type 2 Diabetic Participants". The purpose of this study is to evaluate mouth rinse formulations for oral soft tissue tolerance and efficacy in plaque/ gingivitis prevention/reduction in Type 1 and Type 2 diabetics when used twice daily as an adjunct to tooth brushing during a twelve-week treatment period.
What is the current status of trial NCT04449952?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 154 participants. The study started on 2019-12-02. Estimated completion is 2020-03-06.
What interventions are being tested in trial NCT04449952?
The interventions under investigation include: Colgate Cavity Protection Toothpaste (OTHER), 5% Hydroalcohol Mouth Rinse (OTHER), Listerine Cool Mint (OTHER), Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula (OTHER), Concept Curve Winter Series Toothbrush (DEVICE).
Who is sponsoring clinical trial NCT04449952?
This trial is sponsored by Johnson & Johnson Consumer Inc. (J&JCI), which has 40 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04449952's enrollment target sits among peer trials
154 528th of 2000 higher than 1,471 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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
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