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Anti-caries Potential of a Sodium Monofluorophosphate Dentifrice

This study is currently recruiting participants.
Verified April 2013 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01657877
First received: August 2, 2012
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR).


Condition Intervention Phase
Caries
 Drug: calcium sodium phosphosilicate
Drug: fluoride
Drug: fluoride-free
 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:

MedlinePlus related topics: Calcium Tooth Decay
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Surface Microhardness (SMH) Recovery [ Time Frame: after 21 days twice daily use ] [ Designated as safety issue: No ]
    Enamel remineralization potential, as measured by SMH after 21 days twice daily dentifrice use.


Secondary Outcome Measures:
  • Enamel fluoride uptake (EFU) [ Time Frame: after 21 days twice daily dentifrice use ] [ 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: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High level fluoride with calcium sodium phosphosilicate
toothpaste containing high ppm fluoride with calcium sodium phosphosilicate
 Drug: calcium sodium phosphosilicate
toothpaste
Active Comparator: Calcium sodium phosphosilicate toothpaste
toothpaste containing calcium sodium phosphosilicate
 Drug: calcium sodium phosphosilicate
toothpaste
Placebo Comparator: Fluoride-free
toothpaste containing no fluoride - reference comparator
 Drug: fluoride-free
toothpaste
Low level fluoride
toothpaste containing low ppm fluoride - reference comparator
 Drug: fluoride
toothpaste
Active Comparator: High level fluoride
toothpaste containing high ppm fluoride
 Drug: fluoride
toothpaste

  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: April 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Fluorides
 Fluorophosphate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cariostatic Agents
Protective Agents

ClinicalTrials.gov processed this record on May 21, 2013