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NCT04123665 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
NCT04123665: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04123665 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 98 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04123665, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.
Primary Outcome
BI-to assess bleeding elicited on probing as a measure of gingival condition. Gingivae were air dried and examiner assessed bleeding using a probe which was gently inserted into gingival crevice to depth of approximately(app)1millimeter(mm)and run around tooth(angle of app60\[degrees(deg)\] to long axis of tooth), gently stretching epithelium while sweeping from interproximal to interproximal along sulcular epithelium. BI assessed on facial and lingual gingival surfaces of each scorable tooth(7i
Interventions
- DRUG Stannous fluoride
- DRUG Sodium monofluorophosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2013-05-28 |
| Est. Completion | 2013-12-11 |
| Phase | Phase 3 |
What the finished NCT04123665 record still lists
NCT04123665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Stannous fluoride is the first listed.
NCT04123665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04123665 about?
NCT04123665 is a clinical study titled "A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride". The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.
What is the current status of trial NCT04123665?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2013-05-28. Estimated completion is 2013-12-11.
What interventions are being tested in trial NCT04123665?
The interventions under investigation include: Stannous fluoride (DRUG), Sodium monofluorophosphate (DRUG).
Who is sponsoring clinical trial NCT04123665?
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 NCT04123665's enrollment target sits among peer trials
98 1714th of 2000 higher than 283 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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