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NCT03296072 · ClinicalTrials.gov registry record · Phase 3
In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste
A Phase 3 study of Tooth Erosion, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
- 1
- Study location
NCT03296072: Completed Phase 3 study of Tooth Erosion, sponsored by GlaxoSmithKline.
NCT03296072 is a Phase 3 study of Tooth Erosion that has completed, run by GlaxoSmithKline. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 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
NCT03296072, a Phase 3 study of Tooth Erosion, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice containing 0.254 Percent weight by weight \[%, w/w\] sodium fluoride (1150 parts per million \[ppm\] fluoride) and 5% KNO3 \[potassium nitrate\]), comparator (dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) and placebo (Fluoride free placebo containing 5% KNO3 \[0 ppm fluoride\] ) dentifrices 2 and 4 hours (hrs) post treatment application, based on surface micro hardness measurements. This study will be carried out in healthy adults with a maxillary dental arch suitable for the retention of the palatal appliance.
Primary Outcome
The %SMHR was calculated to assess the changes in mineralization status of enamel specimens. The mean indent length (micrometer) from five Knoop microindentations within each specimen was measured at baseline (B), after the first erosive challenge (E1), and after 2 and 4 hours intraoral phase (R). An increase in the indentation length compared to the baseline indicates softening of the enamel surface while decrease in the indentation length represents re-hardening of enamel surface. The %SMHR wa
Conditions Studied
Interventions
- DRUG 0.254% w/w sodium fluoride and 5% KNO3
- DRUG 0.454% w/w stannous fluoride
- DRUG 5% KNO3
Study Locations (1)
Indiana
- GSK Investigational Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2017-11-13 |
| Est. Completion | 2018-01-16 |
| Phase | Phase 3 |
What the finished NCT03296072 record still lists
NCT03296072 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Tooth Erosion appearing as the primary indexed condition, and to 3 interventions - of which 0.254% w/w sodium fluoride and 5% KNO3 is the first listed.
NCT03296072 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT03296072 about?
NCT03296072 is a clinical study titled "In Situ Erosion Study to Investigate the Effectiveness of an Experimental Toothpaste". This will be a randomized, controlled, single center, single- blind, 3 period, 3 treatment, cross-over, in situ design which consists of placing pre-eroded bovine enamel specimens intra orally using a palatal appliance and testing the remineralizing performance of the experimental (dentifrice contai...
What is the current status of trial NCT03296072?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2017-11-13. Estimated completion is 2018-01-16.
What conditions does trial NCT03296072 study?
This clinical trial studies the following conditions: Tooth Erosion.
What interventions are being tested in trial NCT03296072?
The interventions under investigation include: 0.254% w/w sodium fluoride and 5% KNO3 (DRUG), 0.454% w/w stannous fluoride (DRUG), 5% KNO3 (DRUG).
Who is sponsoring clinical trial NCT03296072?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03296072 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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62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
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