Phase 3
N=57
In Situ Caries Efficacy of Fluoride Toothpastes
Caries
Bottom Line
View on ClinicalTrials.gov: NCT00708097 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) — 28.31; 26.32 Percentage SMHR — p=0.5757
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NaF (Drug); Placebo (Drug); NaMFP (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF) |
28.31; 26.32 | 0.5757 |
| SECONDARY Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF) |
28.31; 26.32; 26.13; 25.52; 53.38 | 0.5387 |
| SECONDARY Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF) |
34.62; 36.06; 31.12; 27.15; 11.10 | 0.5451 |
| SECONDARY Enamel Fluoride Uptake (Sound Enamel Specimens) |
648.06; 650.07; 541.16; 487.14; 425.59 | 0.9697 |
| SECONDARY Enamel Fluoride Uptake (Demineralized Specimens) |
2499.47; 2513.37; 1923.76; 1861.80; 686.18 | 0.9293 |
Summary
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
Eligibility Criteria
Inclusion Criteria
- Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
- Age:Aged between 18 and 80 years.
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
- General Health: Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or physical examination.
- Fluoride: Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
- Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
- Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and all restorations in a good state of repair
- Salivary flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 milliliter (mL)/minute; gum base stimulated whole saliva flow rate = 0.8 mL/minute)
Exclusion Criteria
- Pregnancy: Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
- Breast-feeding:Women who are breast-feeding.
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.
- Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
- Personnel: a) A member of the site study staff living in same household.b)An employee of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or family member
Data sourced from ClinicalTrials.gov (NCT00708097). 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.