Phase 3
Completed N=55
A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
Source: ClinicalTrials.gov NCT01607411 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcomePrimary: Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice — 30.72; 29.49; 28.29; 25.13 %SMHR — p=<0.0001
Summary
An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice |
30.72; 29.49; 28.29; 25.13 | <0.0001 sig |
| SECONDARY %SMHR of Enamel Specimens Exposed to Test Treatments |
30.72; 29.49; 28.29 | 0.2225 |
| SECONDARY Percent Net Acid Resistance (%NAR) of Enamel Specimens |
-19.72; -19.52; -25.82; -54.38 | <0.0001 sig |
| SECONDARY Enamel Fluoride Uptake |
1.76; 1.77; 1.47; 0.98 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01607411). 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. Informational only — not medical advice.