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Experimental Dentifrice Remineralization/ Fluoride Uptake in an In Situ Model

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00752089
First received: September 11, 2008
Last updated: September 12, 2008
Last verified: September 2008
History of Changes
  Purpose

During each of the four treatment periods, subjects wore partial dentures containing two partially demineralized enamel specimens for two weeks- 24 hours per day, except when brushing (twice daily) with test dentifrice. Following each treatment period, the enamel specimen chips were removed and analyzed using Surface MicroHardness and microdrill enamel biopsy technique.


Condition Intervention Phase
Enamel Remineralization
Dental Caries
 Drug: Fluoride
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Exploratory Evaluation of an Experimental Fluoride Dentifrice Formulation Using an In Situ Remineralization/Fluoride Uptake 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 compare the remineralization potential and fluoride uptake of an experimental dentifrice formulation to placebo formulation.

Secondary Outcome Measures:
  • To generate learnings regarding the relative remineralization potential and fluoride uptake between the experimental test dentifrices, currently marketed and placebo controls

Estimated Enrollment: 25
Study Start Date: September 2007
  Eligibility

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

Inclusion Criteria

  1. Age Aged between 18 and 78
  2. Fluoride Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons

  3. Dentures

    • 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 mm)
    • Willing and capable of wearing their removable partial dentures 24 hours per day during the experimental periods
  4. 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
  5. Salivary flow Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 mL/min; gum base stimulated whole saliva flow rate = 0.8 mL/min)
  6. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions
  7. 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
  8. 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

4.3 Exclusion Criteria

  1. Antibiotics Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
  2. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  3. Pregnancy Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
  4. Breast-feeding Women who are breast-feeding.
  5. Clinical Study/Experimental Medication Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit

4) Personnel An employee of the sponsor or the study site who is directly involved in the study

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752089

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, BSc, MSc, PhD, MRSC(CChem) GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00752089     History of Changes
Other Study ID Numbers: Z3120510
Study First Received: September 11, 2008
Last Updated: September 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Enamel remineralization
enamel fluoride uptake
caries

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

ClinicalTrials.gov processed this record on May 16, 2013