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Enamel Remineralization Potential of Dentifrices in Situ

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ClinicalTrials.gov Identifier: NCT01128946
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : November 3, 2013
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Dental Caries Drug: NaF Drug: SnF Drug: NaMFP Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model
Study Start Date : November 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) [ Time Frame: Baseline to 14 days ]
    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 :
  1. %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 ]
    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.

  2. 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 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01128946


Locations
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United States, Indiana
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
More Information
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01128946    
Other Study ID Numbers: T3500690
First Posted: May 24, 2010    Key Record Dates
Results First Posted: November 3, 2013
Last Update Posted: January 1, 2015
Last Verified: December 2014
Keywords provided by GlaxoSmithKline:
Enamel remineralization
Fluoride
caries
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases