Effect of Dentifrice Usage Regime on Efficacy of Fluoride in Situ

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: February 16, 2012
Last updated: February 27, 2014
Last verified: February 2014

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), enamel fluoride uptake (EFU) and reduction in acid-softening of enamel post-treatment (percent net acid resistance, % NAR).

Condition Intervention Phase
Dental Caries
Drug: Fluoride Toothpaste
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in the percentage surface micro harness (% SMH) recovery [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]
    Percentage surface microhardness (% SMH) recovery

  • Change from baseline in Enamel Fluoride Uptake [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]
    enamel fluoride uptake (EFU)

  • Change from baseline in percentage increase in resistance to acid demineralization [ Time Frame: after 14 days of treatment ] [ Designated as safety issue: No ]
    percentage increase in resistance to acid demineralization (% Net Acid Resistance)

Secondary Outcome Measures:
  • Number of participants with treatment-emergent oral soft tissue abnormalities [ Time Frame: after 19 days (including a 5 day follow-up) ] [ Designated as safety issue: Yes ]
  • Number of participants with adverse events [ Time Frame: after 19 days (including a 5 day follow-up) ] [ Designated as safety issue: Yes ]

Enrollment: 65
Study Start Date: January 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Marketed Toothpaste
1150ppm NaF toothpaste
Drug: Fluoride Toothpaste
comparison of different doses of fluoride (1150ppm and 250ppm ) applied for different durations
Active Comparator: Control Toothpaste
250 ppm NaF toothpaste
Drug: Fluoride Toothpaste
comparison of different doses of fluoride (1150ppm and 250ppm ) applied for different durations
Placebo Comparator: Washout Totothpaste
no active, 0ppm Fluoride toothpaste
Drug: Placebo
fluoride-free toothpaste


Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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


  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563172

United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563172     History of Changes
Other Study ID Numbers: T3158587
Study First Received: February 16, 2012
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014