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NCT01607411 · ClinicalTrials.gov registry record · Phase 3
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
A Phase 3 study of Dental Caries, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT01607411: Completed Phase 3 study of Dental Caries, sponsored by GlaxoSmithKline.
NCT01607411 is a Phase 3 study of Dental Caries that has completed, run by GlaxoSmithKline. The registered enrollment target is 55 participants, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01607411, a Phase 3 study of Dental Caries, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
Primary Outcome
Surface microhardness recovery (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), afte
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluoride
Study Locations (1)
Indiana
- Indiana University School of Dentistry - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2012-02 |
| Est. Completion | 2012-05 |
| Phase | Phase 3 |
What the finished NCT01607411 record still lists
NCT01607411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01607411 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT01607411 about?
NCT01607411 is a clinical study titled "A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model". An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
What is the current status of trial NCT01607411?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 55 participants. The study started on 2012-02. Estimated completion is 2012-05.
What conditions does trial NCT01607411 study?
This clinical trial studies the following conditions: Dental Caries.
What interventions are being tested in trial NCT01607411?
The interventions under investigation include: Placebo (DRUG), Fluoride (DRUG).
Who is sponsoring clinical trial NCT01607411?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01607411 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dental Caries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01607411's enrollment target sits among peer trials
55 16th of 30 higher than 15 of 30 other Dental Caries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dental Caries 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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