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

NCT02195583 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-05-01

Study results available
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Summary

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.

Conditions

  • Oral Hygiene

Interventions

DRUG

Sodium fluoride (1426 ppm)

Non-zinc, 1426ppm 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

DRUG

Sodium fluoride (250 ppm)

Non-zinc, 250ppm 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

DRUG

Sodium fluoride (1426 ppm) + zinc base B

Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base

DRUG

Fluoride (0 ppm)

Non-zinc, 0ppm fluoride in a silica gel base

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195583 on ClinicalTrials.gov