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NCT04763044 · ClinicalTrials.gov registry record · Phase 4

Evaluation of the Fluoride Dose Response Using In Situ Caries Model

A Phase 4 study, sponsored by Procter and Gamble.

Completed
Registry status
Phase 4
Development phase
15
Enrollment target

NCT04763044: Completed Phase 4 study, sponsored by Procter and Gamble.

NCT04763044 is a Phase 4 study that has completed, run by Procter and Gamble. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04763044, a Phase 4 study, has completed, sponsored by Procter and Gamble.

COMPLETED
Registry status
Phase 4
Development phase
15 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.

Primary Outcome

The EFU test will evaluate the level of fluoride in partially demineralized enamel specimens via the microdrill enamel biopsy technique by \[Sakkab et al., 1984\]. The calculated scores will be measured in μg F/cm2.

Interventions

  • DRUG 0 ppm F
  • DRUG 250 ppm F as MFP
  • DRUG 1100 ppm as MFP
  • DRUG 2800 ppm F as MFP
  • DRUG 1100 ppm SnF2

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2021-03-01
Est. Completion 2021-07-21
Phase Phase 4
Procter and Gamble

70 total trials

What the finished NCT04763044 record still lists

NCT04763044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which 0 ppm F is the first listed.

NCT04763044 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04763044 about?

NCT04763044 is a clinical study titled "Evaluation of the Fluoride Dose Response Using In Situ Caries Model". The purpose of this study is to evaluate the fluoride dose response of different dentifrice fluoride concentrations - 0, 250, 1100 and 2800 ppm fluoride as sodium monofluorophosphate (MFP) and a fifth leg of 1100 ppm Stannous Fluoride (SnF2) using an in situ caries model.

What is the current status of trial NCT04763044?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2021-03-01. Estimated completion is 2021-07-21.

What interventions are being tested in trial NCT04763044?

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), 1100 ppm SnF2 (DRUG).

Who is sponsoring clinical trial NCT04763044?

This trial is sponsored by Procter and Gamble, which has 70 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04763044's enrollment target sits among peer trials

15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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

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Source: ClinicalTrials.gov NCT04763044, the US trial registry maintained by the National Library of Medicine. NCT04763044 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.