A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01607411
First received: February 16, 2012
Last updated: August 7, 2014
Last verified: July 2014
  Purpose

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.


Condition Intervention Phase
Dental Caries
Drug: Fluoride
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.


Secondary Outcome Measures:
  • %SMHR of Enamel Specimens Exposed to Test Treatments [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    Surface microhardness recovery (SMHR) test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMHR was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

  • Percent Net Acid Resistance (%NAR) of Enamel Specimens [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.

  • Enamel Fluoride Uptake [ Time Frame: Baseline to 4 hours ] [ 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 amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.


Enrollment: 55
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fluoride free toothpaste
toothpaste with no fluoride
Drug: Placebo
Fluoride free toothpaste
Experimental: 1426ppm Fluoride Toothpaste
Experimental toothpaste containing 1426 ppm Fluoride
Drug: Fluoride
Fluoride Toothpaste
Experimental: 1000 ppm Fluoride Toothpaste
Experimental toothpaste containing 1000 ppm Fluoride
Drug: Fluoride
Fluoride Toothpaste
Experimental: 500 ppm Toothpaste
Experimental toothpaste containing 500 ppm Fluoride
Drug: Fluoride
Fluoride Toothpaste

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Exclusion Criteria:

-

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01607411

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

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01607411     History of Changes
Other Study ID Numbers: RH01390
Study First Received: February 16, 2012
Results First Received: May 30, 2013
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 01, 2014