Phase 2
N=20
Experimental Dentifrice Remineralization/Fluoride Uptake in an in Situ Model
Dental Erosion
Bottom Line
View on ClinicalTrials.gov: NCT00752089 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens — 39.46; 38.31; 36.17; 17.26 % SMHR — p=0.7756
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NaF/ KNO3/isopentane Dentifrice (Drug); NaF/KNO3 Dentifrice (Drug); NaF Dentifrice (Drug); Placebo Dentifrice (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jan 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Surface Micro-hardness Recovery (SMHR) of Enamel Specimens |
39.46; 38.31; 36.17; 17.26 | 0.7756 |
| SECONDARY Adjusted Mean Change From Baseline in Enamel Fluoride Uptake |
2445.86; 2767.30; 2518.54; 661.18 | 0.1990 |
Summary
The purpose of this study is to determine whether an experimental fluoridated dentifrice is effective in the treatment of dental caries
Eligibility Criteria
Inclusion Criteria
- Age: Aged between 18 and 78
- Fluoride: Currently living in the Indianapolis area which has a fluoridated water supply (1 ppm F) and not taking fluoride supplements for medical reasons
- Dentures: Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 mm). Willing and capable of wearing their removable 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 participants 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 mL/min; gum base stimulated whole saliva flow rate ≥ 0.8 mL/min
- Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
- 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
- General Health: Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with participant safety during the study period
Exclusion Criteria
- Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- 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.
- Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
- Personnel: An employee of the sponsor or the study site who is directly involved in the study
Data sourced from ClinicalTrials.gov (NCT00752089). 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.