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NCT04750902 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children
A Phase 2 study of Dental Caries, sponsored by Colgate Palmolive.
- Completed
- Registry status
- Phase 2
- Development phase
- 2,000
- Enrollment target
- 9
- Study locations
NCT04750902: Completed Phase 2 study of Dental Caries, sponsored by Colgate Palmolive.
NCT04750902 is a Phase 2 study of Dental Caries that has completed, run by Colgate Palmolive. The registered enrollment target is 2,000 participants, above the 655-participant average among 30 other Dental Caries trials with a reported enrollment target (205% higher). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04750902, a Phase 2 study of Dental Caries, has completed, sponsored by Colgate Palmolive.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2,000 participants
- Enrollment target
- 9
- Study locations
Study Summary
The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.
Primary Outcome
The Decayed Missing or Filled Surfaces (DMFS) score is a measure of the extent of dental caries for a subject, defined as the number of scorable tooth surfaces among the up to 128 examined surfaces in the subject's mouth that were determined by the examiner to be decayed, missing, or filled. This score can range between 0 and 128, with higher values indicating a greater level of disease (i.e., worse condition). The Incremental DMFS is defined as the change in DMFS score between two examinations
Conditions Studied
Interventions
- DRUG 0.24% Sodium Fluoride Dentifrice
- DRUG 1.5% Arginine Dentifrice
- DRUG 4.0% Arginine Dentifrice
- DRUG 8.0% Arginine Dentifrice
Study Locations (9)
Massachusetts
- Tufts University School of Dental Medicine - Boston
- The Forsyth Institute - Boston
California
- Loma Linda University School of Dentistry - Loma Linda
Florida
- University of Florida College of Dentistry - Gainesville
Indiana
- Indiana University School of Dentistry - Indianapolis
New York
- University at Buffalo School of Dental Medicine - Buffalo
Pennsylvania
- University of Pennsylvania School of Dental Medicine - Philadelphia
Texas
- UT Health San Antonio School of Dentistry - San Antonio
Other
- University of Puerto Rico School of Dental Medicine - San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,000 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 2 |
What the finished NCT04750902 record still lists
NCT04750902 is an interventional study that assigns participants to a tested intervention. Its 2,000 participants enrollment target places it among the larger protocols in the corpus, above the 655-participant average among 30 other Dental Caries trials with a reported enrollment target (205% higher).
The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 4 interventions - of which 0.24% Sodium Fluoride Dentifrice is the first listed.
NCT04750902 lists 9 locations in 8 states (Massachusetts, California, Florida).
Frequently Asked Questions
What is clinical trial NCT04750902 about?
NCT04750902 is a clinical study titled "A Clinical Trial to Assess the Safety and the Anti-caries Efficacy of COL 101 (Arginine) Non-fluoride Dentifrices in Comparison With 0.24% Sodium Fluoride (1100 Ppm F) Dentifrice Control in 10 to 14-year-old Children". The objective of this study is to assess the safety and to evaluate the anti-caries efficacy of COL101 (arginine) non-fluoride dentifrices compared to a 0.24% sodium fluoride dentifrice in 10-14 year-old children over a one year period.
What is the current status of trial NCT04750902?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2,000 participants. The study started on 2021-01-21. Estimated completion is 2024-02-29.
What conditions does trial NCT04750902 study?
This clinical trial studies the following conditions: Dental Caries.
What interventions are being tested in trial NCT04750902?
The interventions under investigation include: 0.24% Sodium Fluoride Dentifrice (DRUG), 1.5% Arginine Dentifrice (DRUG), 4.0% Arginine Dentifrice (DRUG), 8.0% Arginine Dentifrice (DRUG).
Who is sponsoring clinical trial NCT04750902?
This trial is sponsored by Colgate Palmolive, which has 51 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04750902 being conducted?
This trial has 9 study locations across California, Florida, Indiana, Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04750902's enrollment target sits among peer trials
2,000 4th of 30 higher than 27 of 30 other Dental Caries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dental Caries 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.
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