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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 is a Phase 1 study of Hyposalivation that has completed, run by University of Michigan. The registered enrollment target is 20 participants. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04239872
The ClinicalTrials.gov registry entry for NCT04239872 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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