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NCT04620252 · ClinicalTrials.gov registry record · Early Phase 1
Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride
A Early Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT04620252 is a Early Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 18 participants.
The verdict
NCT04620252, a Early Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances fluoride concentration in the mouth and the anticaries effect of fluoride. The hypothesis of this study is that the same can be achieved by chewing a calcium supplement prior to a fluoride rinse. The first goal is to determine if chewing these calcium supplements will increase calcium concentration in the oral fluids above baseline levels. Secondly, the calcium supplement with the highest calcium release will be tested before a fluoride rinse to assess the increased retention of fluoride in the oral fluids when compared with the fluoride rinse alone. In both parts, healthy volunteers will participate and saliva will be collected to assess calcium and fluoride concentration.
Interventions
- DRUG Inactive supplement
- DRUG Tricalcium phosphate supplement
- DRUG Calcium carbonate supplement
- DRUG Calcium citrate supplement
- DRUG Inactive supplement and fluoride mouthwash
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-03-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04620252
The ClinicalTrials.gov registry entry for NCT04620252 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 18 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 0 conditions, and to 5 interventions - of which Inactive supplement is the first listed.
NCT04620252 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04620252 about?
NCT04620252 is a clinical study titled "Effect of Chewing a Calcium Supplement Before Fluoride Rinse on Salivary Fluoride". The anticaries effect of fluoride is through the increase in fluoride presence and retention in the oral fluids, reducing dental demineralization and enhancing remineralization. Previous studies showed that a preapplication of calcium (in a rinse) prior to administration of fluoride greatly enhances...
What is the current status of trial NCT04620252?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2021-02-01. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT04620252?
The interventions under investigation include: Inactive supplement (DRUG), Tricalcium phosphate supplement (DRUG), Calcium carbonate supplement (DRUG), Calcium citrate supplement (DRUG), Inactive supplement and fluoride mouthwash (DRUG).
Who is sponsoring clinical trial NCT04620252?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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