Phase 2
N=36
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
Tooth Erosion
Bottom Line
View on ClinicalTrials.gov: NCT01128972 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: 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 — -2.88; -14.54; -29.48; -40.05 Percent NER — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sodium fluoride (Drug); Sodium monoflurophosphate (Drug); Sterile water (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-2.88; -14.54; -29.48; -40.05 | <0.0001 sig |
| SECONDARY 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 |
42.14; 38.02; 30.88; 30.57 | 0.0083 sig |
Summary
An in situ model will be used to evaluate and compare enamel remineralization of bovine enamel specimens.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01128972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.