In Situ Caries Efficacy of Fluoride Toothpastes
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00708097
First received: July 1, 2008
Last updated: August 26, 2008
Last verified: August 2008
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Purpose
This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Volunteers Partial Denture Wearers |
Drug: Fluoride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- To use an in situ caries model to compare a test sodium fluoride toothpaste to an existing sodium fluoride toothpaste with respect to protection of enamel from demineralization.
Secondary Outcome Measures:
- Between treatment comparisons with respect to protection of enamel from demineralization. Comparisons between treatments with respect to enamel remineralization potential. Comparisons between treatments with respect to enamel fluoride uptake.
| Estimated Enrollment: | 57 |
| Study Start Date: | April 2008 |
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
- 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.
- 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
- Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Participation in another GSKCH investigational dental product study within 7 days of first study treatment
- Previous participation in this study.
- Substance abuse Recent history (within the last year) of alcohol or other substance abuse.
Personnel
- A member of the site study staff living in same household.
- An employee of the sponsor.
- Any employee of any toothpaste manufacturer or their spouse or family member
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00708097 History of Changes |
| Other Study ID Numbers: | T3508565 |
| Study First Received: | July 1, 2008 |
| Last Updated: | August 26, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
in situ caries enamel fluoride remineralization |
Additional relevant MeSH terms:
|
Fluorides Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013