Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Early Phase 1 study, sponsored by University of Michigan.
NCT04620252 is a Early Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Saliva collected as one spit, immediately before chewing one of the calcium supplements to be tested in Arm 1. Calcium concentration determined using a colorimetric method.
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 |
What the finished NCT04620252 record still lists
NCT04620252 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 5 interventions - of which Inactive supplement is the first listed.
NCT04620252 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04620252's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01245179 · 18 participants · Phase 1
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
- NCT01999361 · 18 participants · NA
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss
- NCT02359825 · 18 participants · Phase 1
Nerve Repair Using Hydrophilic Polymers to Promote Immediate Fusion of Severed Axons and Swift Return of Function
- NCT02870244 · 18 participants · Phase 1
Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI