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NCT05601154 · ClinicalTrials.gov registry record · Early Phase 1
Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses
A Early Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
NCT05601154: Completed Early Phase 1 study, sponsored by University of Michigan.
NCT05601154 is a Early Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05601154, a Early Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, over the age of 18 years-old, from both genders, with normal oral health conditions and salivary flow rate, no need of urgent dental needs, from the Ann Arbor, MI area. Participants will be recruited from the University of Michigan School of Dentistry, in Ann Arbor, MI. Using a crossover design, twenty participants will be rotating through 4 different combinations of fluoride toothpaste (over-the-counter or prescription concentration) and fluoride mouth rinse (yes or no), in a 2 x 2 factorial design. Treatments to be tested will be as followed: Group #1 will brush with 1,100 ppm F (over-the-counter) toothpaste; Group #2 will brush with 1,100 ppm F (over-the-counter) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse; Group #3 will brush with 5,000 ppm F (prescription) toothpaste; Group #4 will brush with 5,000 ppm F (prescription) toothpaste and rinse with over-the-counter 226 ppm F mouthrinse.
Primary Outcome
Fluoride concentration in saliva will be measured before (baseline) and up to 60 min after the interventions, and the area under the curve of fluoride concentration versus time will be calculated to estimate bioavailability
Interventions
- DRUG Crest Cavity Protection toothpaste
- DRUG Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse
- DRUG Colgate PreviDent 5000+ toothpaste
- DRUG Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-03-23 |
| Est. Completion | 2025-02-28 |
| Phase | Early Phase 1 |
What the finished NCT05601154 record still lists
NCT05601154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which Crest Cavity Protection toothpaste is the first listed.
NCT05601154 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05601154 about?
NCT05601154 is a clinical study titled "Fluoride in Saliva After Use of Fluoride Toothpastes Followed by Fluoride Mouthrinses". This study will evaluate fluoride (F) bioavailability in saliva when using an over-the-counter mouthrinse of 226 ppm F, immediately after brushing with an over-the-counter toothpaste of 1,100 ppm F or a prescription toothpaste of 5,000 ppm F. The study population will include twenty individuals, ove...
What is the current status of trial NCT05601154?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2023-03-23. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT05601154?
The interventions under investigation include: Crest Cavity Protection toothpaste (DRUG), Crest Cavity Protection toothpaste followed by Act Mint Fluoride Rinse (DRUG), Colgate PreviDent 5000+ toothpaste (DRUG), Colgate PreviDent 5000+ toothpaste followed by Act Mint Fluoride Rinse (DRUG).
Who is sponsoring clinical trial NCT05601154?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05601154's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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