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NCT02399163 · ClinicalTrials.gov registry record · NA
Evaluation of Oral Hygiene Products in an In Situ Caries Model
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT02399163: Completed NA study, sponsored by GlaxoSmithKline.
NCT02399163 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02399163, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineralized enamel specimens, as measured by Surface MicroHardness Recovery (%SMHR). This will be a single center, randomized, laboratory analyst blinded, placebo, four treatment, cross-over study in healthy participants. Participants will be assessed at baseline and at the beginning and end of each treatment visit to monitor clinical efficacy and safety.
Primary Outcome
SMHR test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was performed ex-vivo and 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 re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at b
Interventions
- DRUG Fluoride toothpaste
- DRUG Fluoride mouthwash
- DRUG Fluoride free toothpaste
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-04 |
| Est. Completion | 2015-08 |
| Phase | NA |
What the finished NCT02399163 record still lists
NCT02399163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 3 interventions - of which Fluoride toothpaste is the first listed.
NCT02399163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02399163 about?
NCT02399163 is a clinical study titled "Evaluation of Oral Hygiene Products in an In Situ Caries Model". The study will evaluate and compare the potential anti-caries efficacy of a test regimen: placebo (fluoride free) toothpaste (twice daily use) plus fluoride mouthwash (once daily use), in comparison with brushing with a placebo toothpaste alone (twice daily use), to remineralize previously demineral...
What is the current status of trial NCT02399163?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2015-04. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02399163?
The interventions under investigation include: Fluoride toothpaste (DRUG), Fluoride mouthwash (DRUG), Fluoride free toothpaste (DRUG).
Who is sponsoring clinical trial NCT02399163?
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 NCT02399163's enrollment target sits among peer trials
80 994th of 2000 higher than 941 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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