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NCT02751320 · ClinicalTrials.gov registry record · NA
Efficacy of Three Toothpastes Using an in Situ Caries Model
A NA study of Dental Caries, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- NA
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT02751320 is a NA study of Dental Caries that has completed, run by GlaxoSmithKline. The registered enrollment target is 58 participants, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02751320, a NA study of Dental Caries, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- NA
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of human dental enamel (4x3mm) that have been previously demineralized in vitro to form either S or low-R lesions (2 specimens of each lesion type will be used with each participant). After 14 days of twice daily product use off-site, the 2 S lesion specimens will be removed at the study site, with the remaining 2 low-R lesion specimens removed at the study site after a further 14 days of product use. To determine the remineralization ability of the treatments, all specimens will be analyzed by transverse microradiography (TMR) and enamel fluoride uptake (EFU), with the S lesions additionally analyzed by surface micro hardness (SMH) and the low-R lesions additionally analyzed by quantitative light fluorescence (QLF).
Conditions Studied
Interventions
- DRUG 0.425 % w/w phytate,1150ppm F
- DRUG 0.85 % w/w phytate,1150ppm F
- DRUG 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F
- OTHER 0 ppm F
- DRUG 1150ppm F
Study Locations (1)
Indiana
- GSK Investigational Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2016-02-01 |
| Est. Completion | 2016-08-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02751320
The ClinicalTrials.gov registry entry for NCT02751320 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 720-participant average among 30 other Dental Caries trials with a reported enrollment target (92% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dental Caries appearing as the primary indexed condition, and to 5 interventions - of which 0.425 % w/w phytate,1150ppm F is the first listed.
NCT02751320 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT02751320 about?
NCT02751320 is a clinical study titled "Efficacy of Three Toothpastes Using an in Situ Caries Model". This will be a single-centre, randomized, blinded, placebo-controlled, 6-treatment, 4-period crossover, incomplete block design, in situ caries study in healthy adults who wear a removable bilateral mandibular partial denture. The denture will be modified to accommodate 4 gauze-covered specimens of ...
What is the current status of trial NCT02751320?
This trial is currently completed. It is a NA study. The enrollment target is 58 participants. The study started on 2016-02-01. Estimated completion is 2016-08-11.
What conditions does trial NCT02751320 study?
This clinical trial studies the following conditions: Dental Caries.
What interventions are being tested in trial NCT02751320?
The interventions under investigation include: 0.425 % w/w phytate,1150ppm F (DRUG), 0.85 % w/w phytate,1150ppm F (DRUG), 0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F (DRUG), 0 ppm F (OTHER), 1150ppm F (DRUG).
Who is sponsoring clinical trial NCT02751320?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02751320 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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