Last updated: 11/04/2018 12:46:30

In situ caries of fluoride toothpastes

GSK study ID
T3157503
See study documents
Clinicaltrials.gov ID
NCT00708123
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: Comparison of the clinical efficacy from the retention phase of fluoride delivery of fluoride toothpastes using an in situ caries model
Trial description: This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean Percentage surface microhardness recovery (%SMHR) of enamel specimens exposed to NaF/Carbopol toothpaste (1400 ppmF), NaF toothpaste (1350ppmF) compared to NaMFP/NaF toothpaste (1450ppmF)

Timeframe: Baseline to 14 days

Secondary outcomes:

Mean %SMHR of enamel specimens exposed to NaF/Carbopol toothpaste (1400 ppmF), NaF toothpaste (1350ppmF), NaMFP/NaF toothpaste (1450ppmF), NaF toothpaste (250ppmF) and Placebo toothpaste (0ppmF)

Timeframe: Baseline to 14 days

Adjusted mean change from baseline in enamel fluoride uptake

Timeframe: Baseline to 14 days

Interventions:
  • Drug: Sodium fluoride toothpaste
  • Drug: Placebo toothpaste
    • Enrollment:
    60
    Primary completion date:
    2008-30-04
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Healthy Subjects, partial denture wearers, Caries
    Product
    fluoride
    Collaborators
    Not applicable
    Study date(s)
    November 2007 to April 2008
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 78 years
    Accepts healthy volunteers
    Yes
    • 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.
    Inclusion and exclusion criteria
    Inclusion 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 78 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/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period. 5. Diagnosis: Oral
    • i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. 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). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair. 6. 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 1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required. 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. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient. 5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit. 6. Fluoride:Taking fluoride supplements for medical reasons. 7. Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects. 8. Personnel: a) A member of the site study staff, 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
    2008-30-04
    Actual study completion date
    2008-30-04

    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