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Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01128972
First received: April 30, 2010
Last updated: January 23, 2014
Last verified: September 2013
  Purpose

An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.


Condition Intervention Phase
Tooth Erosion
Drug: Sodium fluoride
Drug: Sodium monoflurophosphate
Drug: Sterile water
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adjusted Mean Percent Net Erosion Resistance (NER) of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1) Test Dentifrice+ Sterile Water Rinse 2) Reference Dentifrice+ Sterile Water Rinse 3) Placebo Dentifrice+ Sterile Water Rinse [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.


Secondary Outcome Measures:
  • Adjusted Mean Percentage Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to: 1)Test Dentifrice+Sterile Water Rinse 2)Reference Dentifrice+Sterile Water Rinse 3)Placebo Dentifrice+ Sterile Water Rinse [ Time Frame: Baseline, 4 hours post treatment in each treatment period. ] [ Designated as safety issue: No ]
    SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.


Other Outcome Measures:
  • Adjusted Mean Percent NER of Enamel Specimens Exposed to a Treatment Regimen of Placebo Dentifrice + Test MR Relative to: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water Rinse 3) Reference Dentifrice +Sterile Water Rinse [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.

  • Adjusted Mean Percentage SMH Recovery of Enamel Specimens Exposed to Test Dentifrice + Test MR Relative to Following Treatment Regimens: 1) Test Dentifrice +Test MR 2) Test Dentifrice + Sterile Water 3) Reference Dentifrice +Sterile Water [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.

  • Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    Enamel specimens were exposed to dietary erosive challenge and set of five indentations within each specimen was measured. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NER which compared the indentations values of enamel specimens at baseline (B), first erosive (E1) and second erosive challenge (E2). Percent NER was calculated by formula: [(E1-E2)/ (E1-B)]*100. Smaller the negative NER, better is treatment regimen in imparting resistance to enamel.

  • Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse [ Time Frame: Baseline, 4 hours post treatment in each treatment period ] [ Designated as safety issue: No ]
    SMH test was used to assess mineralization status of enamel specimens using a 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 while decrease in the indentation length represents rehardening of enamel surface. Percent SMH recovery was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first erosive challenge (E1) using formula: [(E1-R)/ (E1-B)]*100.


Enrollment: 36
Study Start Date: August 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Dentifrice + Test Mouth Rinse (MR)
Test fluoride dentifrice and test fluoride MR
Drug: Sodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
Experimental: Test Dentifrice + Sterile Water Rinse
Test fluoride dentifrice and sterile water rinse
Drug: Sodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
Drug: Sterile water
Sterile water rinse
Experimental: Placebo Dentifrice + Test MR
Placebo dentifrice and test fluoride rinse
Drug: Sodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
Active Comparator: Reference Dentifrice + Sterile Water Rinse
Marketed fluoride dentifrice with sterile water rinse
Drug: Sodium fluoride
Test fluoride toothpaste and test fluoride mouth rinse
Drug: Sodium monoflurophosphate
United Kingdom marketed fluoride toothpaste
Drug: Sterile water
Sterile water rinse
Placebo Comparator: Placebo Dentifrice + Sterile Water Rinse
Placebo dentifrice and sterile water rinse
Drug: Sterile water
Sterile water rinse

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • An intact maxillary dental arch suitable for the retention of the palatal appliance and an intact mandibular dental arch - subjects may have fixed bridges replacing missing teeth
  • No current active caries or periodontal disease that may compromise the study or the health of the subjects
  • A gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute and an unstimulated whole saliva flow rate greater than or equal to 0.2 mL/minute

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
  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: NCT01128972

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: NCT01128972     History of Changes
Other Study ID Numbers: Z3480664
Study First Received: April 30, 2010
Results First Received: September 13, 2012
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
tooth erosion
tooth remineralization
enamel erosion

Additional relevant MeSH terms:
Tooth Erosion
Stomatognathic Diseases
Tooth Diseases
Tooth Wear
Fluorides
Listerine
Sodium Fluoride
Anti-Infective Agents
Anti-Infective Agents, Local
Cariostatic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014