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

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

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

Conditions
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Tooth Erosion

Intervention / Treatment
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* Drug: Sodium fluoride
* Drug: Sodium monoflurophosphate
* Drug: Sterile water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Dentifrice + Test Mouth Rinse (MR)<br>Test fluoride dentifrice and test fluoride MR | Drug: Sodium fluoride<br>* Test fluoride toothpaste and test fluoride mouth rinse<br>|
| Experimental: Test Dentifrice + Sterile Water Rinse<br>Test fluoride dentifrice and sterile water rinse | Drug: Sodium fluoride<br>* Test fluoride toothpaste and test fluoride mouth rinse<br>Drug: Sterile water<br>* Sterile water rinse<br>|
| Experimental: Placebo Dentifrice + Test MR<br>Placebo dentifrice and test fluoride rinse | Drug: Sodium fluoride<br>* Test fluoride toothpaste and test fluoride mouth rinse<br>|
| Active Comparator: Reference Dentifrice + Sterile Water Rinse<br>Marketed fluoride dentifrice with sterile water rinse | Drug: Sodium fluoride<br>* Test fluoride toothpaste and test fluoride mouth rinse<br>Drug: Sodium monoflurophosphate<br>* United Kingdom marketed fluoride toothpaste<br>Drug: Sterile water<br>* Sterile water rinse<br>|
| Placebo Comparator: Placebo Dentifrice + Sterile Water Rinse<br>Placebo dentifrice and sterile water rinse | Drug: Sterile water<br>* Sterile water rinse<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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enamel erosion, tooth remineralization, tooth erosion