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
  Purpose

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.


Condition Intervention Phase
Dental Caries
Drug: NaF
Drug: SnF
Drug: NaMFP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • %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.


Enrollment: 83
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluoride Toothpaste 1
Fluoride toothpaste containing sodium fluoride (NaF)
Drug: NaF
Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.
Experimental: Fluoride Toothpaste 2
Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
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)
Experimental: Fluoride Toothpaste 3
Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
Drug: NaF
Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.
Drug: NaMFP
Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
Active Comparator: Reference Dentifrice
Low fluoride toothpaste containing NaF
Drug: NaF
Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

  Eligibility

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

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.
  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: NCT01128946

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: NCT01128946     History of Changes
Other Study ID Numbers: T3500690
Study First Received: May 20, 2010
Results First Received: March 21, 2013
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Fluoride
caries
Enamel remineralization

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

ClinicalTrials.gov processed this record on September 22, 2014