In Situ Caries Model of Fluoride Toothpastes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01005966
First received: October 15, 2009
Last updated: June 20, 2013
Last verified: November 2012
  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: Sodium Fluoride Toothpaste
Drug: Amine Fluoride Toothpaste
Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
Drug: Placebo
Drug: 675 ppmf toothpaste
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).


Secondary Outcome Measures:
  • Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.

  • Change From Baseline in Enamel Fluoride Uptake Potential [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.


Enrollment: 65
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
Run in
Placebo
Drug: Placebo
placebo and washout treatment
Experimental: Sodium Fluoride Toothpaste
Sodium fluoride toothpaste
Drug: Sodium Fluoride Toothpaste
Test product
Active Comparator: Amine Fluoride Toothpaste
Amine Fluoride
Drug: Amine Fluoride Toothpaste
Test product
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005966

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01005966     History of Changes
Other Study ID Numbers: T3508605
Study First Received: October 15, 2009
Results First Received: November 28, 2012
Last Updated: June 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
remineralization
enamel
in situ
fluoride
caries

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Fluorophosphate
Listerine
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014