A Study to Assess the Ingestion of Dentifrice by Children

NCT ID: NCT02409836

Last Updated: 2015-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1993-05-31

Study Completion Date

1993-07-31

Brief Summary

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The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.

Detailed Description

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Conditions

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Healthy Individuals

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Crest Cavity Protection

Marketed Dentifrice

Group Type ACTIVE_COMPARATOR

Marketed Dentifrice

Intervention Type DRUG

Marketed Dentifrice

Crest for Kids Hawaiian Punch Paste

Marketed Dentifrice

Group Type ACTIVE_COMPARATOR

Marketed Flavored Dentifrice

Intervention Type DRUG

Hawaiian Punch Flavored

Crest for Kids Bubble Gum Paste

Marketed Dentifrice

Group Type ACTIVE_COMPARATOR

Marketed Flavored Dentifrice

Intervention Type DRUG

Bubble Gum Flavored

Interventions

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Marketed Dentifrice

Marketed Dentifrice

Intervention Type DRUG

Marketed Flavored Dentifrice

Hawaiian Punch Flavored

Intervention Type DRUG

Marketed Flavored Dentifrice

Bubble Gum Flavored

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Be between the ages of 2 and 12, inclusive
* Be healthy, with no illness that, in the judgment of the investigator or examining dentist, would interfere with the conduct of the test
* Be currently, and have been for at least three months immediately prior to the start of the study, brushing (or being brushed by care giver) their teeth on a daily basis
* Have parent/guardian complete and return the consent form

Exclusion Criteria

* Have diabetes
* Be on dialysis
* Have an oral health condition that, in judgment of investigator or study medical personnel, could interfere with the conduct of the study.
* Wear metal braces
* Have an incomplete or missing consent form
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John E Wild

Role: PRINCIPAL_INVESTIGATOR

HIlltop Research Inc.

Locations

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Hill Top Research, Inc.

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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000393

Identifier Type: -

Identifier Source: org_study_id

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