A Study to Assess the Ingestion of Dentifrice by Children

Healthy Individuals Clinical Trial

Official title:

A Study to Assess the Ingestion of Dentifrice by Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02409836
• Other study ID #: 000393
• Status: Completed
• Phase: N/A
• First received: March 24, 2015
• Last updated: April 1, 2015
• Start date: May 1993
• Est. completion date: July 1993

Study information

• Verified date: April 2015
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 1993
• Est. primary completion date: July 1993
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Individuals

Intervention

Drug:
• Marketed Dentifrice
Marketed Dentifrice
• Marketed Flavored Dentifrice
Hawaiian Punch Flavored
• Marketed Flavored Dentifrice
Bubble Gum Flavored

Locations

Country	Name	City	State
United States	Hill Top Research, Inc.	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Procter and Gamble

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of dentifrice ingested and used by various age groups of children.		10 weeks	Yes
Secondary	Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.		10 weeks	Yes