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NCT06735235 · ClinicalTrials.gov registry record · Phase 1
Salivary Fluoride Clearance
A Phase 1 study of Caries, sponsored by Procter and Gamble.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT06735235: Completed Phase 1 study of Caries, sponsored by Procter and Gamble.
NCT06735235 is a Phase 1 study of Caries that has completed, run by Procter and Gamble. The registered enrollment target is 27 participants, below the 56-participant average among 7 other Caries trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06735235, a Phase 1 study of Caries, has completed, sponsored by Procter and Gamble.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Subjects will provide saliva samples at baseline and at 2, 6, 12, and 30 minutes post-treatment. The F- concentrations in each saliva sample will be determined by ion chromatography
Primary Outcome
The primary endpoint will be AUC of the fluoride levels from 2 to 30 minutes. AUC will be calculated for each subject and treatment combination by integrating a 3 parameter first order decay model curve estimate (y= theta1 \* exp (-theta2.X) + theta3). For any values obtained for a timepoint that are below the detection limit, 0.5 times the detection limit will be used. The following rules will apply if a subject has missing value(s) before the AUC is calculated: * If 2 or more timepoints are m
Conditions Studied
Interventions
- DRUG 0 ppm F
- DRUG 250 ppm F as MFP
- DRUG 1100 ppm as MFP
- DRUG 2800 ppm F as MFP
Study Locations (1)
Ohio
- Oral Health Science Center - Mason
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-07-14 |
| Est. Completion | 2021-07-29 |
| Phase | Phase 1 |
What the finished NCT06735235 record still lists
NCT06735235 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 56-participant average among 7 other Caries trials with a reported enrollment target (52% lower).
The record links to 1 condition, with Caries appearing as the primary indexed condition, and to 4 interventions - of which 0 ppm F is the first listed.
NCT06735235 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06735235 about?
NCT06735235 is a clinical study titled "Salivary Fluoride Clearance". This is a single-center, four-treatment, four-period crossover study. Over the course of the study, up to thirty qualified subjects will use four (4) study treatment products, one time each according to the randomization. Subjects will brush with 1.25g of the assigned study product at each visit. Su...
What is the current status of trial NCT06735235?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2021-07-14. Estimated completion is 2021-07-29.
What conditions does trial NCT06735235 study?
This clinical trial studies the following conditions: Caries.
What interventions are being tested in trial NCT06735235?
The interventions under investigation include: 0 ppm F (DRUG), 250 ppm F as MFP (DRUG), 1100 ppm as MFP (DRUG), 2800 ppm F as MFP (DRUG).
Who is sponsoring clinical trial NCT06735235?
This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06735235 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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