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

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

Study Overview

• Status: Completed
• Conditions: Tooth Erosion
• Intervention / Treatment: Drug: Sodium fluoride; Drug: Sterile water; Drug: Sodium monoflurophosphate

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / 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: Sterile water; Sterile water rinse; Drug: Sodium monoflurophosphate; United Kingdom marketed fluoride toothpaste
PLACEBO_COMPARATOR: Placebo Dentifrice + Sterile Water Rinse; Placebo dentifrice and sterile water rinse	Drug: Sterile water; Sterile water rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 4 hours post treatment in each treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 4 hours post treatment in each treatment period.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Baseline, 4 hours post treatment in each treatment period
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	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.	Baseline, 4 hours post treatment in each treatment period
Adjusted Mean Percent NER of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	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.	Baseline, 4 hours post treatment in each treatment period
Adjusted Mean Percent SMH Recovery of Enamel Specimens Exposed to Test Dentifrice +Sterile Water Rinse and Reference Dentifrice +Sterile Water Rinse	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.	Baseline, 4 hours post treatment in each treatment period

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Maggio B, Guibert RG, Mason SC, Karwal R, Rees GD, Kelly S, Zero DT. Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model. J Dent. 2010 Nov;38 Suppl 3:S37-44. doi: 10.1016/S0300-5712(11)70007-0.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): October 1, 2009
• Study Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 20, 2010
• First Posted (ESTIMATE): May 24, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): January 1, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: enamel erosion; tooth erosion; tooth remineralization
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Wear; Tooth Erosion; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: Z3480664