Last updated: 11/04/2018 10:25:08

Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions

GSK study ID
RH01299
See study documents
Clinicaltrials.gov ID
NCT01641237
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: The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ
Trial description: The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Percentage Surface Microhardness Recovery (%SMHR) dose response relationship

Timeframe: Baseline to 4 hours

Secondary outcomes:

%SMHR

Timeframe: Baseline to 4 hours

Percentage Relative Erosion Resistance

Timeframe: Baseline to 4 hours

Enamel Fluoride Uptake (Corrected Data)

Timeframe: Baseline to 4 hours

Interventions:
  • Drug: sodium fluoride
  • Drug: no added fluoride in a silica base
    • Enrollment:
    72
    Primary completion date:
    2012-31-05
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    enamel erosion
    Product
    sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    March 2012 to May 2012
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Inclusion Criteria:
    • intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria:
    • intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.

    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
    2012-31-05
    Actual study completion date
    2012-31-05

    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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