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

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ClinicalTrials.gov Identifier: NCT01128972
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : April 25, 2013
Last Update Posted : January 1, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.

Condition or disease Intervention/treatment Phase
Tooth Erosion Drug: Sodium fluoride Drug: Sodium monoflurophosphate Drug: Sterile water Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
Study Start Date : August 2009
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. 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. ]
    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:
  1. 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 ]
    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.

  2. 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 ]
    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.

  3. 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 ]
    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.

  4. 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 ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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): 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
First Posted: May 24, 2010    Key Record Dates
Results First Posted: April 25, 2013
Last Update Posted: January 1, 2015
Last Verified: December 2014

Keywords provided by GlaxoSmithKline:
enamel erosion
tooth remineralization
tooth erosion

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