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

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ClinicalTrials.gov Identifier: NCT01607411
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : August 26, 2013
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE February 16, 2012
First Posted Date  ICMJE May 30, 2012
Results First Submitted Date  ICMJE May 30, 2013
Results First Posted Date  ICMJE August 26, 2013
Last Update Posted Date August 11, 2014
Study Start Date  ICMJE February 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice [ Time Frame: Baseline to 4 hours ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
Percent surface microhardness (SMH) Recovery [ Time Frame: Change from Baseline to 4 hours post brushing ]
To use an in situ caries model to compare three children's sodium fluoride toothpastes to a fluoride free (placebo) toothpaste with respect to enamel remineralization potential following a single brushing
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2013)
  • %SMHR of Enamel Specimens Exposed to Test Treatments [ Time Frame: Baseline to 4 hours ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • Enamel fluoride uptake [ Time Frame: Change from Baseline to 4 hours post brushing ]
  • Percent net acid resistance [ Time Frame: Change from 4 hours post brushing to 5 hours post use in vitro demineralization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Official Title  ICMJE A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Drug: Fluoride
    Fluoride Toothpaste
  • Drug: Placebo
    Fluoride free toothpaste
Study Arms  ICMJE
  • Placebo Comparator: Fluoride free toothpaste
    toothpaste with no fluoride
    Intervention: Drug: Placebo
  • Experimental: 1426ppm Fluoride Toothpaste
    Experimental toothpaste containing 1426 ppm Fluoride
    Intervention: Drug: Fluoride
  • Experimental: 1000 ppm Fluoride Toothpaste
    Experimental toothpaste containing 1000 ppm Fluoride
    Intervention: Drug: Fluoride
  • Experimental: 500 ppm Toothpaste
    Experimental toothpaste containing 500 ppm Fluoride
    Intervention: Drug: Fluoride
Publications * Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2:31-8. doi: 10.1111/idj.12073.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2012)
55
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01607411
Other Study ID Numbers  ICMJE RH01390
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date July 2014

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