Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
This study is currently recruiting participants.
Verified June 2013 by GlaxoSmithKline
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657877
First received: August 2, 2012
Last updated: June 12, 2013
Last verified: June 2013
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Purpose
In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in comparison to an experimental SMFP only dentifrice.
| Condition | Intervention | Phase |
|---|---|---|
|
Caries |
Drug: Calcium sodium phosphosilicate Drug: Sodium monoflurophosphate Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- SMHR [ Time Frame: 21 days ] [ Designated as safety issue: No ]Enamel remineralization potential, as measured by SMHR.
Secondary Outcome Measures:
- EFU [ Time Frame: 21 days ] [ Designated as safety issue: No ]EFU after 21 days twice daily dentifrice use.
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CSP/SMFP Dentifrice
Dentifrice containing high fluoride content as SMFP and CSP
|
Drug: Calcium sodium phosphosilicate
CSP high percentage weight by weight
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
|
|
Active Comparator: SMFP Dentifrice Prototype 1
Dentifrice containing high fluoride content as SMFP and no CSP
|
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
|
|
Active Comparator: SMFP Dentifrice Prototype 2
Dentifrice containing low fluoride content as SMFP and no CSP
|
Drug: Sodium monoflurophosphate
500 to 1500 parts per million (ppm) of fluoride
|
|
Active Comparator: CSP Dentifrice
Dentifrice containing CSP but no fluoride
|
Drug: Calcium sodium phosphosilicate
CSP high percentage weight by weight
|
|
Placebo Comparator: Placebo Dentifrice
Dentifrice containing no CSP and no fluoride
|
Drug: Placebo
No CSP and no fluoride
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657877
Contacts
| Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com |
Locations
| United States, Indiana | |
| Indiana University School of Dentistry | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: US GSK Clinical Trials Call Center 877-379-3718 info@GSKClinicalSupportHD@gsk.com | |
| Contact: EU GSK Clinical Trials Call Center +44 (0) 20 8990 4466 info@GSKClinicalSupportHD@gsk.com | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01657877 History of Changes |
| Other Study ID Numbers: | RH01381 |
| Study First Received: | August 2, 2012 |
| Last Updated: | June 12, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Fluorophosphate Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013