In Situ Caries Model of Fluoride Toothpastes

NCT ID: NCT01005966

Last Updated: 2013-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-03-31

Brief Summary

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

Conditions

Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Run in

Placebo

Group Type: OTHER

Placebo

Intervention Type: DRUG

placebo and washout treatment

Sodium Fluoride Toothpaste

Sodium fluoride toothpaste

Group Type: EXPERIMENTAL

Sodium Fluoride Toothpaste

Intervention Type: DRUG

Test product

Amine Fluoride Toothpaste

Amine Fluoride

Group Type: ACTIVE_COMPARATOR

Amine Fluoride Toothpaste

Intervention Type: DRUG

Test product

675ppmf toothpaste

Dose response

Group Type: OTHER

675 ppmf toothpaste

Intervention Type: DRUG

dose response

Sodium monofluorophosphate/sodium fluoride Toothpaste

Sodium monofluorophosphate/sodium fluoride Toothpaste

Group Type: ACTIVE_COMPARATOR

Sodium monofluorophosphate/Sodium Fluoride Toothpaste

Intervention Type: DRUG

test product

0 ppmf toothpaste

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo and washout treatment

Interventions

Sodium Fluoride Toothpaste

Test product

Intervention Type: DRUG

Amine Fluoride Toothpaste

Test product

Intervention Type: DRUG

Sodium monofluorophosphate/Sodium Fluoride Toothpaste

test product

Intervention Type: DRUG

Placebo

placebo and washout treatment

Intervention Type: DRUG

675 ppmf toothpaste

dose response

Intervention Type: DRUG

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

T3508605

Identifier Type: -

Identifier Source: org_study_id