In Situ Caries Efficacy of Fluoride Toothpastes

Completed · Phase 3 · Has a placebo group

Conditions studied: Caries

In brief

This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model

Key facts

Study ID: NCT00708097
Run by: GlaxoSmithKline
People needed: 57
Starts: 2008-04-01
Expected to finish: 2008-07-01
Last updated by the study team: 2015-01-01

Who can join

Age: 18 and older, up to 78. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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)

You may not qualify if…

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

Where it is running

Indiana University School of Dentistry — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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