Last updated: 11/04/2018 12:47:02

Enamel Remineralization Potential of Dentifrices in situ

GSK study ID
T3500690
See study documents
Clinicaltrials.gov ID
NCT01128946
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 enamel remineralization potential of dentifrices incorporating different fluoride salts using an in situ caries model
Trial description: This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
Primary purpose:
Prevention
Trial design:
Crossover Assignment
Masking:
Double (Participant, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percentage surface microhardness recovery (%SMHR) of enamel specimens exposed to NaF toothpaste (1450ppmF) and SnF/NaF toothpaste (1450ppmF)

Timeframe: Baseline to 14 days

Secondary outcomes:

%SMHR of enamel specimens exposed to NaF toothpaste (1450ppmF), SnF/NaF toothpaste (1450ppmF), NaMFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF)

Timeframe: Baseline to 14 days

Change from baseline in enamel fluoride uptake upon exposure to NaF toothpaste (1450ppmF), SnF/NaF toothpaste (1450ppmF), NaMFP/NaF toothpaste (1450ppmF) and NaF toothpaste (675ppmF)

Timeframe: Baseline to 14 days

Interventions:
  • Drug: NaF
  • Drug: SnF
  • Drug: NaMFP
    • Enrollment:
    83
    Primary completion date:
    2010-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    dental caries
    Product
    sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to April 2010
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    Yes
    • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
    • No current active caries or periodontal disease that may compromise the study or health of the subject.
    • Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
    • Current active caries or periodontal disease that may compromise the study or health of the subject.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
    • No current active caries or periodontal disease that may compromise the study or health of the subject.
    • All restorations in a good state of repair
    • Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
    • Willing to have their denture modified to accomodate enamel test specimens
    • Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
    • Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.
    Exclusion criteria:
    • Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
    • Current active caries or periodontal disease that may compromise the study or health of the subject.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Indiana University School of Dentistry
    Indianapolis, IN, United States, 46202
    Status
    Study Complete
    Contact us

    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
    2010-31-03
    Actual study completion date
    2010-01-04

    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
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