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NCT03478644 · ClinicalTrials.gov registry record · NA
Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe
A NA study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 152
- Enrollment target
NCT03478644: Completed NA study, sponsored by GlaxoSmithKline.
NCT03478644 is a NA study that has completed, run by GlaxoSmithKline. The registered enrollment target is 152 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03478644, a NA study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A methodology was also evaluated to assess the efficacy of the denture wipe at removing food debris as exploratory objective.
Primary Outcome
Proportion of participants experiencing or reporting TE oral AEs on or before 14 days of use treatments were reported. TE AEs include AEs that were identified during an oral soft tissue examination, a dermal assessment or reported by the subject. AEs were categorized as oral or non-oral by the Clinical Research scientist prior to database lock (oral AE's were AEs effecting tissues associated with the oral cavity extending from the labial mucosa to the pharyngeal area).
Interventions
- DEVICE Experimental Denture Wipe
- OTHER Tap Water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2016-10-10 |
| Est. Completion | 2016-10-31 |
| Phase | NA |
What the finished NCT03478644 record still lists
NCT03478644 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Experimental Denture Wipe is the first listed.
NCT03478644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03478644 about?
NCT03478644 is a clinical study titled "Oral and Dermal Tolerability Clinical Study of an Experimental Denture Wipe". The purpose of this two-phase study was to evaluate the oral and dermal tolerance of an experimental, non-rinse denture cleansing wipe after 7 and 14 days of use. In addition, the consumer acceptability of the denture cleansing wipes was also evaluated via a consumer acceptability questionnaire. A m...
What is the current status of trial NCT03478644?
This trial is currently completed. It is a NA study. The enrollment target is 152 participants. The study started on 2016-10-10. Estimated completion is 2016-10-31.
What interventions are being tested in trial NCT03478644?
The interventions under investigation include: Experimental Denture Wipe (DEVICE), Tap Water (OTHER).
Who is sponsoring clinical trial NCT03478644?
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 NCT03478644's enrollment target sits among peer trials
152 658th of 2000 higher than 1,340 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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