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NCT04239872 · ClinicalTrials.gov registry record · Phase 1
Fluoride Retention in the Mouth of Older Adults
A Phase 1 study of Hyposalivation, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04239872: Completed Phase 1 study of Hyposalivation, sponsored by University of Michigan.
NCT04239872 is a Phase 1 study of Hyposalivation that has completed, run by University of Michigan. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04239872, a Phase 1 study of Hyposalivation, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flow of saliva. For these individuals, fluoride is used to maintain a good oral health. Usually, higher fluoride concentration products, such as prescription toothpastes, are recommended. In this project, the ability to increase fluoride retention in the mouth by using calcium before a conventional fluoride rinse will be tested in older adults with a range of salivary flow rates. This approach was never tested in patients with dry mouth, for whom the treatment with calcium may also be beneficial. A crossover, clinical study with two experimental phases will be conducted, in which patients with a range of saliva flows (from normal to dry mouth) will rinse with a fluoride rinse only (used at over the counter concentration), or a fluoride rinse preceded by a calcium rinse. The concentration of fluoride and calcium in the saliva and dental plaque residues will be determined up to two hours after the rinse(s), to test the effect of the approach to optimize fluoride retention in the mouth of patients with dry mouth.
Primary Outcome
Dental biofilm was collected at baseline (before mouthwash(es)), and the fluid phase was separated using centrifugation. Fluoride concentration in the dental biofilm fluid was measured using an ion-specific electrode adapted for microanalysis.
Conditions Studied
Interventions
- DRUG Fluoride mouthwash
- DRUG Calcium and fluoride mouthwash
Study Locations (1)
Michigan
- School of Dentistry, University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2021-04-05 |
| Phase | Phase 1 |
What the finished NCT04239872 record still lists
NCT04239872 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Hyposalivation appearing as the primary indexed condition, and to 2 interventions - of which Fluoride mouthwash is the first listed.
NCT04239872 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT04239872 about?
NCT04239872 is a clinical study titled "Fluoride Retention in the Mouth of Older Adults". Individuals with dry mouth (a reduction in the production of saliva) suffer from high rates of oral diseases. Dry mouth is a common problem among older individuals, because many medications to control chronic conditions (such as blood pressure, bladder-control problems and depression) reduce the flo...
What is the current status of trial NCT04239872?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2020-03-11. Estimated completion is 2021-04-05.
What conditions does trial NCT04239872 study?
This clinical trial studies the following conditions: Hyposalivation.
What interventions are being tested in trial NCT04239872?
The interventions under investigation include: Fluoride mouthwash (DRUG), Calcium and fluoride mouthwash (DRUG).
Who is sponsoring clinical trial NCT04239872?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04239872 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04239872's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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