A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-05-31

Brief Summary

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An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

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Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Fluoride free toothpaste

toothpaste with no fluoride

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Fluoride free toothpaste

1426ppm Fluoride Toothpaste

Experimental toothpaste containing 1426 ppm Fluoride

Group Type EXPERIMENTAL

Fluoride

Intervention Type DRUG

Fluoride Toothpaste

1000 ppm Fluoride Toothpaste

Experimental toothpaste containing 1000 ppm Fluoride

Group Type EXPERIMENTAL

Fluoride

Intervention Type DRUG

Fluoride Toothpaste

500 ppm Toothpaste

Experimental toothpaste containing 500 ppm Fluoride

Group Type EXPERIMENTAL

Fluoride

Intervention Type DRUG

Fluoride Toothpaste

Interventions

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Fluoride

Fluoride Toothpaste

Intervention Type DRUG

Placebo

Fluoride free toothpaste

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).