Clinical trial NCT00708123: In Situ Caries of Fluoride Toothpastes
Official title: Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Subjects
Partial Denture Wearers
Caries
Keywords: remineralization
enamel
fluoride
caries
in situ
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 60
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: Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources \[sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)\] using an in situ caries model.

Eligibility criteria: Inclusion Criteria

1. 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.
2. Age:Aged between 18 and 78 years.
3. Compliance:Understands and is willing, able and likely to comply with all study procedures and restrictions.
4. 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 subject safety during the study period.
5. Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. 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 millimeters (mm). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.
6. Salivary Flow:Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate = 0.2 ml/minute; gum base stimulated whole saliva flow rate = 0.8 ml/minute).

Exclusion Criteria

1. Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
2. Breast-feeding:Women who are breast-feeding.
3. Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
4. Clinical Study/Experimental Medication:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
5. Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
6. Fluoride:Taking fluoride supplements for medical reasons.
7. Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects.
8. Personnel: a) A member of the site study staff, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.

Primary outcomes:
measure: Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
timeFrame: Baseline to 14 days
Secondary outcomes:
measure: Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
timeFrame: Baseline to 14 days
measure: Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
timeFrame: Baseline to 14 days
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: