In Situ Caries Efficacy of Fluoride Toothpastes

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00708097
First received: July 1, 2008
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Partial Denture Wearers
Drug: Fluoride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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:
  • To use an in situ caries model to compare a test sodium fluoride toothpaste to an existing sodium fluoride toothpaste with respect to protection of enamel from demineralization.

Secondary Outcome Measures:
  • Between treatment comparisons with respect to protection of enamel from demineralization. Comparisons between treatments with respect to enamel remineralization potential. Comparisons between treatments with respect to enamel fluoride uptake.

Estimated Enrollment: 57
Study Start Date: April 2008
  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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.
  2. Age Aged between 18 and 80 years.
  3. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions.
  4. General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
  5. Fluoride Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
  6. Dentures

    1. Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side.
    2. Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
  7. Dental health Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and all restorations in a good state of repair
  8. Salivary flow Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute)

Exclusion Criteria:

  1. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
  2. Breast-feeding Women who are breast-feeding.
  3. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  4. Antibiotics Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
  5. Clinical Study/Experimental Medication

    1. Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
    2. Participation in another GSKCH investigational dental product study within 7 days of first study treatment
    3. Previous participation in this study.
  6. Substance abuse Recent history (within the last year) of alcohol or other substance abuse.
  7. Personnel

    1. A member of the site study staff living in same household.
    2. An employee of the sponsor.
    3. 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: NCT00708097

Locations
United States, Indiana
GSK Clinical Trials Call Centre
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, DDS GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00708097     History of Changes
Other Study ID Numbers: T3508565
Study First Received: July 1, 2008
Last Updated: August 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
in situ
caries
enamel
fluoride
remineralization

Additional relevant MeSH terms:
Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013