Last updated: 11/04/2018 13:50:30

Evaluation of efficacy of experimental gel to foam dentifrices in dental erosion

GSK study ID
Z6961385
Clinicaltrials.gov ID
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: A Placebo Controlled Study to Evaluate the Effectiveness of Experimental Foaming Gel Toothpastes Using an In-situ Erosion Remineralization Model
Trial description: The purpose of this study is to compare and evaluate the ability of two European Union (EU) regulated gel to foam toothpaste formulations versus a non-fluoride toothpaste using a modified in-situ model of dental erosion and remineralization. A positive control i.e fluoride containing toothpaste marketed in EU will also be compared to non-fluoride toothpaste.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Relative erosion resistance (RER) of enamel specimens post 4 hours of treatment exposure

Timeframe: Baseline, 4 hours post treatment in each treatment period

Surface microhardness (SMH) recovery of enamel specimens post 4 hours of treatment exposure

Timeframe: Baseline, 4 hours post treatment in each treatment period

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Sodium Fluoride
  • Drug: Potassium nitrate
  • Enrollment:
    56
    Primary completion date:
    2012-29-02
    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)
    November 2011 to February 2012
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • General and Oral Health: Good general health with (in the opinion of the investigator) no clinically OST and OHT examinations.
    • Oral Requirements:
    • Oral Health:
    • – Current active caries or periodontal disease that may compromise the study or the health of the subjects.

    Trial location(s)

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

    Study documents

    Scientific result summary
    Available language(s): English

    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
    2012-29-02
    Actual study completion date
    2012-29-02

    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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