The Effect of Experimental Dentifrices on Remineralization of Caries Lesions In-situ

April 9, 2015 updated by: GlaxoSmithKline
This study will evaluate the effect of experimental sodium fluoride-silica dentifrice formulations, with and without zinc, on remineralization of enamel in situ. Following the remineralization phase, the acid resistance of the new mineral formed will be assessed. Fluoride uptake during the remineralization phase will also be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Good general health with no clinically significant and relevant abnormalities of medical history or oral examination
  • Participants with maxillary dental arch suitable for the retention of the palatal appliance

Exclusion Criteria:

  • Participants taking fluoride supplement
  • Pregnant or breast-feeding women

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sodium fluoride (1426 ppm)
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Drug: Sodium fluoride (1426 ppm)
Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1150 ppm)
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Drug: Sodium fluoride (1150 ppm)
Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (250 ppm)
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Drug: Sodium fluoride (250 ppm)
Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1426 ppm) + zinc base A
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Drug: Sodium fluoride (1426 ppm) + zinc base A
Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
Experimental: Sodium fluoride (1426 ppm) + zinc base B
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Drug: Sodium fluoride (1426 ppm) + zinc base B
Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
Placebo Comparator: Fluoride (0 ppm)
Non-zinc, 0ppm fluoride in a silica gel base
Drug: Fluoride (0 ppm)
Non-zinc, 0ppm fluoride in a silica gel base

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Surface Microhardness Recovery (% SMHR)
Time Frame: Baseline to 4 hours
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the Surface Microhardness (SMH) Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was determined prior to the in vitro acid challenge. SMH was determined again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The extent of remineralization was calculated as the % recovery in SMH using the equation: % SMHR= [(D1-R)/(D1-B)]*100 Where B = indentation length (μm) of sound enamel at baseline; D1 = indentation length (μm) after first acid challenge; R = indentation length (μm) after in situ remineralization.
Baseline to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enamel Fluoride Uptake
Time Frame: Baseline to 4 hours
The microdrill enamel biopsy technique was used to analyze the fluoride uptake by enamel. Each enamel specimen was mounted on the long axis of a drill attached to a microdrill and drilled to a depth of approximately 100 micrometer (μm) through the entire lesion (four cores per specimen). The enamel powder pooled from four drilling sample was then immediately analyzed for fluoride content using fluoride specific electrode and pH/ion meter. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores and expressed as microgram per square centimeter (μg/cm^2).
Baseline to 4 hours
Percentage Net Acid Resistance (% NAR)
Time Frame: Baseline to 4 hours
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % NAR was calculated using the equation: % NAR= [(D1-D2)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; D1= Indentation length (μm) after first acid challenge and D2= Indentation length (μm) after second acid challenge.
Baseline to 4 hours
Percentage Comparative Acid Resistance (% CAR)
Time Frame: Baseline to 4 hours
Changes in the mineral content of the four centrally-located enamel specimens were evaluated using the SMH Test. The SMH was measured using a Wilson 2100 Hardness Tester. The baseline SMH was measured prior to the in vitro acid challenge. SMH was measured again after the in vitro acid challenge, after the in situ remineralization test, and again after the second in vitro acid challenge. The % CAR was calculated using the equation: % CAR= [(D2-R)/(D1-B)]*100 where B= Indentation length (μm) of sound enamel at baseline; R= Indentation length (μm) of enamel after in situ remineralization; D1= Indentation length (μm) after first acid challenge; D2= Indentation length (μm) after second acid challenge.
Baseline to 4 hours

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

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 9, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202194
  • RH02437 (Other Identifier: GSK)

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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