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NCT02195583 · ClinicalTrials.gov registry record · NA
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 62
- Enrollment target
NCT02195583: Completed NA study, sponsored by GlaxoSmithKline.
NCT02195583 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 62 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02195583, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.
Primary Outcome
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the e
Interventions
- DRUG Sodium fluoride (1426 ppm)
- DRUG Sodium fluoride (1150 ppm)
- DRUG Sodium fluoride (250 ppm)
- DRUG Sodium fluoride (1426 ppm) + zinc base A
- DRUG Sodium fluoride (1426 ppm) + zinc base B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2014-06 |
| Est. Completion | 2014-08 |
| Phase | NA |
What the finished NCT02195583 record still lists
NCT02195583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Sodium fluoride (1426 ppm) is the first listed.
NCT02195583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02195583 about?
NCT02195583 is a clinical study titled "The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ". This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineral...
What is the current status of trial NCT02195583?
This trial is currently completed. It is a NA study. The enrollment target is 62 participants. The study started on 2014-06. Estimated completion is 2014-08.
What interventions are being tested in trial NCT02195583?
The interventions under investigation include: Sodium fluoride (1426 ppm) (DRUG), Sodium fluoride (1150 ppm) (DRUG), Sodium fluoride (250 ppm) (DRUG), Sodium fluoride (1426 ppm) + zinc base A (DRUG), Sodium fluoride (1426 ppm) + zinc base B (DRUG).
Who is sponsoring clinical trial NCT02195583?
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 NCT02195583's enrollment target sits among peer trials
62 1157th of 2000 higher than 837 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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