In Situ Caries Model of Fluoride Toothpastes

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Caries

Treatments: Drug: Amine Fluoride Toothpaste; Drug: Placebo; Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste; Drug: Sodium Fluoride Toothpaste; Drug: 675 ppmf toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT01005966

T3508605

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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 18 to 80 years inclusive
• 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/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
• Residency: Currently living in the Indianapolis, Indiana area
• Dentures: a) 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). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) 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 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
• Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
• Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
• Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse
• Substance abuse: Recent history (within last year) of alcohol or other substance abuse
• Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects
• Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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65 participants in 6 patient groups, including a placebo group

Run in

Other group

Description:

Placebo

Treatment:

Drug: Placebo

Sodium Fluoride Toothpaste

Experimental group

Description:

Sodium fluoride toothpaste

Treatment:

Drug: Sodium Fluoride Toothpaste

Amine Fluoride Toothpaste

Active Comparator group

Description:

Amine Fluoride

Treatment:

Drug: Amine Fluoride Toothpaste

675ppmf toothpaste

Other group

Description:

Dose response

Treatment:

Drug: 675 ppmf toothpaste

Sodium monofluorophosphate/sodium fluoride Toothpaste

Active Comparator group

Description:

Sodium monofluorophosphate/sodium fluoride Toothpaste

Treatment:

Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste

0 ppmf toothpaste

Placebo Comparator group

Treatment:

Drug: Placebo