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: November 20, 2014
Last verified: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563172     History of Changes
Other Study ID Numbers: T3158587 
Study First Received: February 16, 2012
Last Updated: November 20, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 27, 2016