Phase 3
Completed N=62
Effect of Fluoride in a Dentifrice on Remineralization of Erosive Lesions
Enamel Erosion
Source: ClinicalTrials.gov NCT01641237 ↗
Enrolled (actual)
62
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship — 30.89; 28.71; 25.28; 21.03 %SMHR — p=<0.0001
Summary
The proposed study will evaluate the performance of fluoride delivered from a new dentifrice formulation without potassium nitrate. It will also evaluate the dose-response to fluoride by testing four dentifrices covering a range of sodium fluoride concentration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (%SMHR) Dose Response Relationship |
30.89; 28.71; 25.28; 21.03 | <0.0001 sig |
| SECONDARY %SMHR |
30.9; 28.7; 25.3; 21.0 | 0.1898 |
| SECONDARY Percentage Relative Erosion Resistance |
-38.83; -39.75; -50.40; -71.21 | <0.0001 sig |
| SECONDARY Enamel Fluoride Uptake (Corrected Data) |
3.13; 3.07; 2.09; 1.47 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- intact maxillary dental arch suitable to retain a palatal appliance, an intact mandibular dental arch and a stimulated/unstimulated saliva flow rate of ≥ 0.8 milliliter/minute (ml/min) and ≥ 0.2 ml/min respectively.
Data sourced from ClinicalTrials.gov (NCT01641237). 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.