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NCT01641237 · ClinicalTrials.gov registry record · Phase 3
Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 72
- Enrollment target
NCT01641237: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01641237 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 72 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01641237, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 72 participants
- Enrollment target
Study Summary
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
Primary Outcome
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after
Interventions
- DRUG sodium fluoride
- DRUG no added fluoride in a silica base
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01641237 record still lists
NCT01641237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which sodium fluoride is the first listed.
NCT01641237 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01641237 about?
NCT01641237 is a clinical study titled "Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions". The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
What is the current status of trial NCT01641237?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2012-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01641237?
The interventions under investigation include: sodium fluoride (DRUG), no added fluoride in a silica base (DRUG).
Who is sponsoring clinical trial NCT01641237?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01641237's enrollment target sits among peer trials
72 1780th of 2000 higher than 217 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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