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Effect of Dentifrice Usage Regime on Efficacy of Fluoride in Situ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563172
First received: February 16, 2012
Last updated: January 24, 2013
Last verified: August 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01563172

Locations
United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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: January 24, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013