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NCT06010732 · ClinicalTrials.gov registry record · Phase 3
In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice
A Phase 3 study of Caries, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT06010732: Completed Phase 3 study of Caries, sponsored by Indiana University.
NCT06010732 is a Phase 3 study of Caries that has completed, run by Indiana University. The registered enrollment target is 52 participants, roughly in line with the 53-participant average among 7 other Caries trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06010732, a Phase 3 study of Caries, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.
Primary Outcome
The SMH test was used to assess changes in the mineral status of partially demineralized enamel specimens. %SMH Recovery = (D1-R)/(D1-B) ×100 B = indentation length (µm) of sound enamel specimen at baseline D1 = indentation length (µm) after in vitro demineralization R = indentation length (µm) after intra-oral exposure.
Conditions Studied
Interventions
- DRUG 0 ppm F (placebo, negative control)
- DRUG 1100 ppm F as sodium fluoride (positive control)
- DRUG 1100 ppm F as sodium fluoride Test Product
Study Locations (1)
Indiana
- Indiana University School of dentistry, Oral Health Research institute 415 Lansing Street - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-10-02 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 3 |
What the finished NCT06010732 record still lists
NCT06010732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, roughly in line with the 53-participant average among 7 other Caries trials with a reported enrollment target.
The record links to 1 condition, with Caries appearing as the primary indexed condition, and to 3 interventions - of which 0 ppm F (placebo, negative control) is the first listed.
NCT06010732 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT06010732 about?
NCT06010732 is a clinical study titled "In Situ Comparison of the Remineralization Potential of Optimized Fluoride Dentifrice With Control Fluoride Dentifrice". The purpose of this study is to compare the remineralization potential of an optimized fluoride dentifrice to a control fluoride dentifrice in an in situ caries model.
What is the current status of trial NCT06010732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2023-10-02. Estimated completion is 2024-02-22.
What conditions does trial NCT06010732 study?
This clinical trial studies the following conditions: Caries.
What interventions are being tested in trial NCT06010732?
The interventions under investigation include: 0 ppm F (placebo, negative control) (DRUG), 1100 ppm F as sodium fluoride (positive control) (DRUG), 1100 ppm F as sodium fluoride Test Product (DRUG).
Who is sponsoring clinical trial NCT06010732?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06010732 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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