Last updated: 11/04/2018 12:46:39

Effect of dentifrice usage regime on delivery and efficacy of fluoride

GSK study ID
T3158587
Clinicaltrials.gov ID
NCT01563172
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: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model
Trial description: This study will evaluate and compare the effect of the amount of toothpaste used and brushing time on enamel strengthening (percent of surface microhardness recovery, % SMHR) and enamel fluoride uptake (EFU).
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Investigator)
Allocation:
Randomized
Primary outcomes:

Percentage surface micro hardness recovery (% SMH), of brushing for 2 minutes versus (vs.) brushing for 45 seconds with 1.5g of experimental dentifrice.

Timeframe: At Baseline and at Day 14

Secondary outcomes:

Percentage Surface Micro hardness (% SMH) recovery , of brushing for 2 minutes vs. brushing for 45 seconds with 0.5g of experimental dentifrice.

Timeframe: At Baseline and at Day 14

Percentage Surface Micro Hardness (% SMH) recovery, of brushing for 2 minutes with 0.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5g of experimental dentifrice.

Timeframe: At Baseline and at Day 14

Percentage Surface Micro-hardness recovery (% SMH), of brushing for 45 seconds with 0.5g of experimental dentifrice vs. brushing for 45 seconds with 1.5g of experimental dentifrice.

Timeframe: At Baseline and at Day 14

Percent Surface Micro-hardness (% SMH) recovery, of brushing for 2 minutes with 1.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5g of an control dentifrice.

Timeframe: At Baseline and at Day 14

Enamel fluoride uptake (EFU) after brushing for 2 minutes vs. brushing for 45 seconds with 1.5g of experimental dentifrice.

Timeframe: At Day 14

Enamel Fluoride Uptake (EFU) after brushing for 2 minutes vs. brushing for 45 seconds with 0.5g of experimental dentifrice.

Timeframe: At Day 14

Enamel Fluoride Uptake (EFU) after brushing for 2 minutes with 0.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5g of experimental dentifrice.

Timeframe: At Day 14

Enamel Fluoride Uptake (EFU) after brushing for 45 seconds with 0.5g of experimental dentifrice vs. brushing for 45 seconds with 1.5g of experimental dentifrice.

Timeframe: At Day 14

Enamel Fluoride Uptake (EFU) after brushing for 2 minutes with 1.5g of experimental dentifrice vs. brushing for 2 minutes with 1.5g of control dentifrice.

Timeframe: At Day 14

Interventions:
  • Drug: Sodium fluoride / silica and carbopol, 0.5g
  • Drug: Sodium fluoride / silica and carbopol, 1.5g
  • Other: Fluoride free dentifrice
    • Enrollment:
    65
    Primary completion date:
    2009-01-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    https://clinicaltrials.gov/ct2/show/results/NCT01563172?term=T3158587&rank=1
    Medical condition
    dental caries
    Product
    sodium fluoride
    Collaborators
    Not applicable
    Study date(s)
    January 2009 to June 2009
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 80 years
    Accepts healthy volunteers
    Yes
    • General and Dental Health
    • Good general and dental health with (in the opinion of the investigator) no
    • Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use
    • during the study treatment periods
    Inclusion and exclusion criteria
    Inclusion criteria:
    • General and Dental Health -Good general and dental health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination -Have no current active caries or periodontal disease that may compromise the study or the health of the subjects -Residency: Currently living in the Indianapolis, Indiana area 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 mm x 7 mm) -Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
    • All restorations in a good state of repair -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:
    • Antibiotics: Use of antibiotics two weeks prior to a treatment visit or anticipated use during the study treatment periods
    • Study Scale Use: Subjects unable to measure product weights accurately using the assigned study scale as determined by the study staff (as demonstrated on or before Visit 4)
    • A member of the site study staff who is directly working on the project or living in that staff’s household
    • Any employee of any toothpaste manufacturer or their spouse or family member

    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

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-01-06
    Actual study completion date
    2009-11-06

    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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