Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Enamel Remineralization Potential of Dentifrices in Situ

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128946
First received: May 20, 2010
Last updated: January 23, 2014
Last verified: August 2013

May 20, 2010
January 23, 2014
November 2009
March 2010   (final data collection date for primary outcome measure)
Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/(D-B)]*100.
Change from baseline in enamel surface microhardness (SMH) [ Time Frame: baseline to 14 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01128946 on ClinicalTrials.gov Archive Site
  • %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    SMH test was used to assess mineral status of partially demineralized enamel specimens using Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening/demineralization, while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline(B), after intra-oral exposure(R) and after in-vitro demineralization(D) using formula: [(D-R)/ (D-B)]*100.
  • Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) [ Time Frame: Baseline to 14 days ] [ Designated as safety issue: No ]
    Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Enamel fluoride uptake [ Time Frame: After 14 days of treatment ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Enamel Remineralization Potential of Dentifrices in Situ
Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model

This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Dental Caries
  • Drug: NaF
    Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.
  • Drug: SnF
    Fluoride toothpaste containing stannous fluoride (1100 ppmF)
  • Drug: NaMFP
    Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
  • Experimental: Fluoride Toothpaste 1
    Fluoride toothpaste containing sodium fluoride (NaF)
    Intervention: Drug: NaF
  • Experimental: Fluoride Toothpaste 2
    Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
    Interventions:
    • Drug: NaF
    • Drug: SnF
  • Experimental: Fluoride Toothpaste 3
    Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
    Interventions:
    • Drug: NaF
    • Drug: NaMFP
  • Active Comparator: Reference Dentifrice
    Low fluoride toothpaste containing NaF
    Intervention: Drug: NaF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
  • No current active caries or periodontal disease that may compromise the study or health of the subject.
  • All restorations in a good state of repair
  • Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
  • Willing to have their denture modified to accomodate enamel test specimens
  • Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
  • Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

Exclusion Criteria:

  • Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
  • Current active caries or periodontal disease that may compromise the study or health of the subject.
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128946
T3500690
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2013

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