This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries
lesions in an in situ model
In situ models represent an acceptable approach for testing the anti-caries potential of
fluoride products. This study is to evaluate the effect of fluoride dentifrice containing
1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in
situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be
compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F),
NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm
F) and placebo toothpaste (0 ppm F).
- 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
- 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)
- 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
- 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