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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: February 27, 2014
Last verified: February 2014

February 16, 2012
February 27, 2014
January 2009
June 2009   (final data collection date for primary outcome measure)
  • 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)
  • Percentage surface microhardness (% SMH) recovery [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
  • enamel fluoride uptake (EFU), [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
  • percentage increase in resistance to acid demineralization (% NAR) [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01563172 on ClinicalTrials.gov Archive Site
  • 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 ]
  • treatment-emergent oral soft tissue abnormalities [ Time Frame: 2 weeks (14 days) ] [ Designated as safety issue: Yes ]
  • AE collection [ Time Frame: (total duration is 16 weeks) ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Effect of Dentifrice Usage Regime on Efficacy of Fluoride in Situ
A Study to Measure the Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride Using an In Situ Caries Model

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Dental Caries
  • Drug: Fluoride Toothpaste
    comparison of different doses of fluoride (1150ppm and 250ppm ) applied for different durations
  • Drug: Placebo
    fluoride-free toothpaste
  • Active Comparator: Marketed Toothpaste
    1150ppm NaF toothpaste
    Intervention: Drug: Fluoride Toothpaste
  • Active Comparator: Control Toothpaste
    250 ppm NaF toothpaste
    Intervention: Drug: Fluoride Toothpaste
  • Placebo Comparator: Washout Totothpaste
    no active, 0ppm Fluoride toothpaste
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01563172
T3158587
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP