Clinical trial NCT00708097: In Situ Caries Efficacy of Fluoride Toothpastes
Official title: Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Caries
Keywords: fluoride
in situ
remineralization
enamel
caries
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Detailed description: 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).

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

Primary outcomes:
measure: Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: 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)
timeFrame: Baseline to 14 days
measure: 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)
timeFrame: Baseline to 14 days
measure: Enamel Fluoride Uptake (Sound Enamel Specimens)
timeFrame: Baseline to 14 days
measure: Enamel Fluoride Uptake (Demineralized Specimens)
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Dentistry
state: Indiana
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: