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NCT05645705 · ClinicalTrials.gov registry record · Phase 4
A Two-Week Study of Clinical Safety and Saliva Flow Quantification
A Phase 4 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- Completed
- Registry status
- Phase 4
- Development phase
- 270
- Enrollment target
NCT05645705: Completed Phase 4 study, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
NCT05645705 is a Phase 4 study that has completed, run by Johnson & Johnson Consumer Inc. (J&JCI). The registered enrollment target is 270 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05645705, a Phase 4 study, has completed, sponsored by Johnson & Johnson Consumer Inc. (J&JCI).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 270 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.
Primary Outcome
Change from baseline in oral tolerance based on oral had and soft tissue exams will be reported. Oral examination will be conducted to monitor oral soft and hard tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal fold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system.
Interventions
- OTHER Colgate Cavity Protection Toothpaste
- OTHER LISTERINE Cool Mint Antiseptic Mouthwash
- OTHER Listerine Advanced Gum Alcohol
- OTHER Listerine Advanced Gum Zero
- OTHER LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2022-11-28 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 4 |
What the finished NCT05645705 record still lists
NCT05645705 is an interventional study that assigns participants to a tested intervention. The registered 270 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 (48% lower).
The record links to 0 conditions, and to 5 interventions - of which Colgate Cavity Protection Toothpaste is the first listed.
NCT05645705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05645705 about?
NCT05645705 is a clinical study titled "A Two-Week Study of Clinical Safety and Saliva Flow Quantification". The purpose of this study is to assess the oral tissue tolerance (tissues within the mouth) for irritation caused by added ingredients in mouthwashes. This will be assessed based on oral tissue exams and adverse reactions.
What is the current status of trial NCT05645705?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 270 participants. The study started on 2022-11-28. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT05645705?
The interventions under investigation include: Colgate Cavity Protection Toothpaste (OTHER), LISTERINE Cool Mint Antiseptic Mouthwash (OTHER), Listerine Advanced Gum Alcohol (OTHER), Listerine Advanced Gum Zero (OTHER), LISTERINE ULTRACLEAN Tartar Control Antiseptic Mouthwash Cool Mint (OTHER).
Who is sponsoring clinical trial NCT05645705?
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 NCT05645705's enrollment target sits among peer trials
270 318th of 2000 higher than 1,682 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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