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Enamel Remineralization Potential of Dentifrices in Situ

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NaF
SnF
NaMFP
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring Enamel remineralization, Fluoride, caries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Indiana University School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Fluoride Toothpaste 1

Fluoride Toothpaste 2

Fluoride Toothpaste 3

Reference Dentifrice

Arm Description

Fluoride toothpaste containing sodium fluoride (NaF)

Fluoride toothpaste containing stannous fluoride (SnF) and NaF.

Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.

Low fluoride toothpaste containing NaF

Outcomes

Primary Outcome Measures

Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)
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)
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)
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.

Full Information

First Posted
May 20, 2010
Last Updated
December 11, 2014
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT01128946
Brief Title
Enamel Remineralization Potential of Dentifrices in Situ
Official Title
Comparison of Enamel Remineralization Potential of Dentifrices Incorporating Different Fluoride Salts Using an in Situ Caries Model
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Enamel remineralization, Fluoride, caries

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fluoride Toothpaste 1
Arm Type
Experimental
Arm Description
Fluoride toothpaste containing sodium fluoride (NaF)
Arm Title
Fluoride Toothpaste 2
Arm Type
Experimental
Arm Description
Fluoride toothpaste containing stannous fluoride (SnF) and NaF.
Arm Title
Fluoride Toothpaste 3
Arm Type
Experimental
Arm Description
Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.
Arm Title
Reference Dentifrice
Arm Type
Active Comparator
Arm Description
Low fluoride toothpaste containing NaF
Intervention Type
Drug
Intervention Name(s)
NaF
Intervention Description
Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.
Intervention Type
Drug
Intervention Name(s)
SnF
Intervention Description
Fluoride toothpaste containing stannous fluoride (1100 ppmF)
Intervention Type
Drug
Intervention Name(s)
NaMFP
Intervention Description
Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
Primary Outcome Measure Information:
Title
Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF)
Description
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.
Time Frame
Baseline to 14 days
Secondary Outcome Measure Information:
Title
%SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF)
Description
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.
Time Frame
Baseline to 14 days
Title
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)
Description
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.
Time Frame
Baseline to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
Indiana University School of Dentistry
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

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Enamel Remineralization Potential of Dentifrices in Situ

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