N/A
N=62
The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ
Oral Hygiene
Bottom Line
View on ClinicalTrials.gov: NCT02195583 ↗Enrolled (actual)
62
Serious AEs
0.3%
Results posted
Apr 2015
Primary outcome: Primary: Percentage Surface Microhardness Recovery (% SMHR) — 32.49; 31.81; 27.56; 22.62 Percentage of SMHR — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sodium fluoride (1426 ppm) (Drug); Sodium fluoride (1150 ppm) (Drug); Sodium fluoride (250 ppm) (Drug); Sodium fluoride (1426 ppm) + zinc base A (Drug); Sodium fluoride (1426 ppm) + zinc base B (Drug); Fluoride (0 ppm) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (% SMHR) |
32.49; 31.81; 27.56; 22.62; 23.22; 24.78 | <0.0001 sig |
| SECONDARY Enamel Fluoride Uptake |
2.94; 2.70; 1.85; 2.62; 2.37; 0.98 | — |
| SECONDARY Percentage Net Acid Resistance (% NAR) |
-12.54; -13.45; -17.81; -17.60; -18.98; -50.60 | — |
| SECONDARY Percentage Comparative Acid Resistance (% CAR) |
45.00; 45.23; 45.44; 40.29; 42.21; 75.41 | — |
Summary
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.
Eligibility Criteria
Inclusion Criteria
- Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
- Participants with maxillary dental arch suitable for the retention of the palatal appliance
Exclusion Criteria
- Participants taking fluoride supplement
- Pregnant or breast-feeding women
Data sourced from ClinicalTrials.gov (NCT02195583). 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.