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

Phase 2CompletedNCT01128972

GlaxoSmithKline36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Tooth Erosion

Interventions

Sodium fluorideDRUG

Test fluoride toothpaste and test fluoride mouth rinse

Sodium monoflurophosphateDRUG

United Kingdom marketed fluoride toothpaste

Sterile waterDRUG

Sterile water rinse

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana University School of Dentistry

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 4 hours post treatment in each treatment period

Secondary Outcomes

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.

Time frame: Baseline, 4 hours post treatment in each treatment period.

Data from ClinicalTrials.gov

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