A Study to Assess the Ingestion of Dentifrice by Children

April 1, 2015 updated by: Procter and Gamble
The objective of this study was to examine the amount of dentifrice ingested and used by various age groups of children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

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
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Hill Top Research, Inc.

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Crest Cavity Protection
Marketed Dentifrice
Drug: Marketed Dentifrice
Marketed Dentifrice
Active Comparator: Crest for Kids Hawaiian Punch Paste
Marketed Dentifrice
Drug: Marketed Flavored Dentifrice
Hawaiian Punch Flavored
Drug: Marketed Flavored Dentifrice
Bubble Gum Flavored
Active Comparator: Crest for Kids Bubble Gum Paste
Marketed Dentifrice
Drug: Marketed Flavored Dentifrice
Hawaiian Punch Flavored
Drug: Marketed Flavored Dentifrice
Bubble Gum Flavored

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Level of dentifrice ingested and used by various age groups of children.
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.
Time Frame: 10 weeks
10 weeks

Collaborators and Investigators

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

Sponsor

Procter and Gamble

Investigators

  • Principal Investigator: John E Wild, HIlltop Research Inc.

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

May 1, 1993

Primary Completion (Actual)

July 1, 1993

Study Completion (Actual)

July 1, 1993

Study Registration Dates

First Submitted

March 24, 2015

First Submitted That Met QC Criteria

April 1, 2015

First Posted (Estimate)

April 7, 2015

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 1, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 000393

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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