Last updated: 11/04/2018 12:47:26

In situ caries model of fluoride toothpastes

GSK study ID
T3508605
See study documents
Clinicaltrials.gov ID
NCT01005966
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Clinical efficacy of fluoride toothpastes using an in situ caries model
Trial description: This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Percent surface microhardness (SMH) recovery of enamel specimens exposed to NaF toothpaste (1426ppmF) and AmF toothpaste (1400ppmF)

Timeframe: Baseline to 14 days

Secondary outcomes:

Percent SMH recovery of enamel specimens exposed to NaF toothpaste (1426ppmF), NaF toothpaste (675ppmF), NaMFP/NaF toothpaste (1400ppm F) and Placebo (0ppmF)

Timeframe: Baseline to 14 days

Change from baseline in enamel fluoride uptake potential

Timeframe: Baseline to 14 days

Interventions:
  • Drug: Sodium Fluoride Toothpaste
  • Drug: Amine Fluoride Toothpaste
  • Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
  • Drug: Placebo
  • Drug: 675 ppmf toothpaste
    • Enrollment:
    65
    Primary completion date:
    2009-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Caries
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    November 2008 to March 2009
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    Yes
    • 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
    • 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
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-31-03
    Actual study completion date
    2009-31-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website