In Situ Caries Model of Fluoride Toothpastes

June 20, 2013 updated by: GlaxoSmithKline

Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Run in
Placebo
Drug: Placebo
placebo and washout treatment
Experimental: Sodium Fluoride Toothpaste
Sodium fluoride toothpaste
Drug: Sodium Fluoride Toothpaste
Test product
Active Comparator: Amine Fluoride Toothpaste
Amine Fluoride
Drug: Amine Fluoride Toothpaste
Test product
Other: 675ppmf toothpaste
Dose response
Drug: 675 ppmf toothpaste
dose response
Active Comparator: Sodium monofluorophosphate/sodium fluoride Toothpaste
Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
test product
Placebo Comparator: 0 ppmf toothpaste
Drug: Placebo
placebo and washout treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
Time Frame: Baseline to 14 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)
Time Frame: Baseline to 14 days
SMH 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. Differences in percent SMH recovery due to study and reference toothpastes were calculated.
Baseline to 14 days
Change From Baseline in Enamel Fluoride Uptake Potential
Time Frame: Baseline to 14 days
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Baseline to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 29, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

July 29, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T3508605

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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