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NCT01657877 · ClinicalTrials.gov registry record · Phase 2
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
A Phase 2 study of Caries, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01657877: Completed Phase 2 study of Caries, sponsored by GlaxoSmithKline.
NCT01657877 is a Phase 2 study of Caries that has completed, run by GlaxoSmithKline. The registered enrollment target is 100 participants, above the 46-participant average among 7 other Caries trials with a reported enrollment target (117% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01657877, a Phase 2 study of Caries, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
Primary Outcome
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Calcium sodium phosphosilicate
- DRUG Sodium monoflurophosphate
Study Locations (1)
Indiana
- Indiana University School of Dentistry - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01657877 record still lists
NCT01657877 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 46-participant average among 7 other Caries trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Caries appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01657877 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01657877 about?
NCT01657877 is a clinical study titled "Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice". In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosil...
What is the current status of trial NCT01657877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2012-05. Estimated completion is 2013-06.
What conditions does trial NCT01657877 study?
This clinical trial studies the following conditions: Caries.
What interventions are being tested in trial NCT01657877?
The interventions under investigation include: Placebo (DRUG), Calcium sodium phosphosilicate (DRUG), Sodium monoflurophosphate (DRUG).
Who is sponsoring clinical trial NCT01657877?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01657877 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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