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In Situ Caries Model of Fluoride Toothpastes

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01005966
First received: October 15, 2009
Last updated: October 29, 2009
Last verified: October 2009
History of Changes
  Purpose

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model


Condition Intervention Phase
Caries
 Drug: 675 ppmf toothpaste
Drug: Sodium Fluoride Toothpaste
Drug: Amine Fluoride Toothpaste
Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model

Resource links provided by NLM:

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To use an in situ caries model to compare fluoride toothpastes with respect to enamel remineralisation potential [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To use an in situ caries model to compare fluoride toothpastes with respect to enamel fluoride uptake [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
675ppmf toothpaste
Dose response
 Drug: 675 ppmf toothpaste
dose response
Active Comparator: Sodium monofluorophosphate/sodium fluoride Toothpaste
Sodium monofluorophosphate/sodium fluoride Toothpaste
 Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
test product
Placebo Comparator: 0 ppmf toothpaste Drug: Placebo
placebo and washout treatment
Experimental: Sodium Fluoride Toothpaste
Sodium fluoride toothpaste
 Drug: Sodium Fluoride Toothpaste
Test product
Run in
Placebo
 Drug: Placebo
placebo and washout treatment
Active Comparator: Amine Fluoride Toothpaste
Amine Fluoride
 Drug: Amine Fluoride Toothpaste
Test product

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
  • Age:Aged 18 to 80 years inclusive
  • Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
  • General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
  • Residency: Currently living in the Indianapolis, Indiana area
  • Dentures: a) Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) All restorations in a good state of repair
  • Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).

Exclusion Criteria:

  • Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
  • Breast-feeding: Women who are breast-feeding
  • Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  • Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
  • Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
  • Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse
  • Substance abuse: Recent history (within last year) of alcohol or other substance abuse
  • Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects
  • Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005966

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT01005966     History of Changes
Other Study ID Numbers: T3508605
Study First Received: October 15, 2009
Last Updated: October 29, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
in situ
caries
enamel
fluoride
remineralization

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Sodium Fluoride
 Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013