Last updated: 11/04/2018 13:49:25

Experimental dentifrice remineralization/fluoride uptake in an in situ model

GSK study ID
Z3120510
See study documents
Clinicaltrials.gov ID
NCT00752089
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: Exploratory evaluation of an experimental fluoride dentifrice formulation using an in situ remineralization/fluoride uptake model
Trial description: The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Percentage Surface Micro-hardness Recovery (SMHR) of enamel specimens

Timeframe: Baseline to 14 days

Secondary outcomes:

Adjusted mean change from baseline in enamel fluoride uptake

Timeframe: Baseline to 14 days

Interventions:
  • Drug: NaF/ KNO3/isopentane Dentifrice
  • Drug: NaF/KNO3 Dentifrice
  • Drug: NaF Dentifrice
  • Other: Placebo Dentifrice
    • Enrollment:
    20
    Primary completion date:
    2008-31-01
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Dental erosion
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    September 2007 to January 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 78 years
    Accepts healthy volunteers
    Yes
    • 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
    • 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
    Inclusion and exclusion 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 participants 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 participant safety during the study period
    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 6. Personnel:An employee of the sponsor or the study site who is directly involved in the study

    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
    2008-31-01
    Actual study completion date
    2008-31-01

    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
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