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

Phase 2

Completed

Interventions: Drug: Sodium fluoride
Drug: Sterile water
Drug: Sodium monoflurophosphate

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

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Reference Dentifrice + Sterile Water Rinse	Sodium monoflurophosphate	Marketed fluoride dentifrice with sterile water rinse
Test Dentifrice + Test Mouth Rinse (MR)	Sodium fluoride	Test fluoride dentifrice and test fluoride MR
Placebo Dentifrice + Sterile Water Rinse	Sterile water	Placebo dentifrice and sterile water rinse
Test Dentifrice + Sterile Water Rinse	Sodium fluoride	Test fluoride dentifrice and sterile water rinse
Placebo Dentifrice + Test MR	Sodium fluoride	Placebo dentifrice and test fluoride rinse
Test Dentifrice + Sterile Water Rinse	Sterile water	Test fluoride dentifrice and sterile water rinse
Reference Dentifrice + Sterile Water Rinse	Sodium fluoride	Marketed fluoride dentifrice with sterile water rinse
Reference Dentifrice + Sterile Water Rinse	Sterile water	Marketed fluoride dentifrice with sterile water rinse

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
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	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.