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Efficacy of Three Toothpastes Using an in Situ Caries Model
NCT02751320 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02751320 reports 1 study location spanning 1 distinct geographic area — top geographies include Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02751320?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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