Phase 4
N=83
Enamel Remineralization Potential of Dentifrices in Situ
Dental Caries
Bottom Line
View on ClinicalTrials.gov: NCT01128946 ↗Enrolled (actual)
83
Serious AEs
0.3%
Results posted
Nov 2013
Primary outcome: Primary: Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) — 40.94; 17.88 Percentage of SMHR — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- NaF (Drug); SnF (Drug); NaMFP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and SnF/NaF Toothpaste (1450ppmF) |
40.94; 17.88 | <0.0001 sig |
| SECONDARY %SMHR of Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) |
40.94; 30.19; 17.88; 28.74 | <0.0001 sig |
| SECONDARY Change From Baseline in Enamel Fluoride Uptake Upon Exposure to NaF Toothpaste (1450ppmF), SnF/NaF Toothpaste (1450ppmF), NaMFP/NaF Toothpaste (1450ppmF) and NaF Toothpaste (675ppmF) |
22.23; 13.54; 9.13; 14.31 | <0.0001 sig |
Summary
This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.
Eligibility Criteria
Inclusion Criteria
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
- No current active caries or periodontal disease that may compromise the study or health of the subject.
- All restorations in a good state of repair
- Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
- Willing to have their denture modified to accomodate enamel test specimens
- Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
- Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.
Exclusion Criteria
- Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
- Current active caries or periodontal disease that may compromise the study or health of the subject.
Data sourced from ClinicalTrials.gov (NCT01128946). 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.