In Situ Caries Model of Fluoride Toothpastes

NCT01005966 | Completed Phase 3 Results

• 1 other identifier: T3508605
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Keywords

remineralization; enamel; in situ; fluoride; caries

Outcome Measures

Primary Outcomes (1)

• Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)

  SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).

  Baseline to 14 days

Secondary Outcomes (2)

• Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)

  Baseline to 14 days

• Change From Baseline in Enamel Fluoride Uptake Potential

  Baseline to 14 days

Study Arms (6)

Run in

OTHER

Placebo

Drug: Placebo

Sodium Fluoride Toothpaste

EXPERIMENTAL

Sodium fluoride toothpaste

Drug: Sodium Fluoride Toothpaste

Amine Fluoride Toothpaste

ACTIVE COMPARATOR

Amine Fluoride

Drug: Amine Fluoride Toothpaste

675ppmf toothpaste

OTHER

Dose response

Drug: 675 ppmf toothpaste

Sodium monofluorophosphate/sodium fluoride Toothpaste

ACTIVE COMPARATOR

Sodium monofluorophosphate/sodium fluoride Toothpaste

Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste

0 ppmf toothpaste

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Sodium Fluoride Toothpaste DRUG

Test product

Sodium Fluoride Toothpaste

Amine Fluoride Toothpaste DRUG

Test product

Amine Fluoride Toothpaste

Sodium monofluorophosphate/Sodium Fluoride Toothpaste DRUG

test product

Sodium monofluorophosphate/sodium fluoride Toothpaste

Placebo DRUG

placebo and washout treatment

0 ppmf toothpaste; Run in

675 ppmf toothpaste DRUG

dose response

675ppmf toothpaste

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Interventions

fluorophosphate

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 29, 2013
• Results First Posted: July 29, 2013

Record last verified: 2012-11