A Study to Assess the Ingestion of Dentifrice by Children | NCT02409836

Studies
A Study to Assess the Ingestion of Dentifrice by Children

NCT02409836

Sponsor

Procter and Gamble

Status

Completed

Last Update Posted

Apr 7, 2015Estimated

Enrollment

90Actual

Phase

Not Applicable

Conditions

Healthy Individuals

Interventions

Marketed Dentifrice
Marketed Flavored Dentifrice
Marketed Flavored Dentifrice

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1993

Primary Completion Date

Jul 1993Actual

Completion Date

Jul 1993Actual

First Submitted Date

Mar 24, 2015

First Submission Date that Met QC Criteria

Apr 1, 2015

First Posted Date

Apr 7, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 1, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Crest Cavity Protection	Active Comparator	Marketed Dentifrice	Drug: Marketed Dentifrice
Crest for Kids Hawaiian Punch Paste	Active Comparator	Marketed Dentifrice	Drug: Marketed Flavored Dentifrice
Crest for Kids Bubble Gum Paste	Active Comparator	Marketed Dentifrice	Drug: Marketed Flavored Dentifrice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Marketed Dentifrice	Drug	Marketed Dentifrice	Crest Cavity Protection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John E Wild	HIlltop Research Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hill Top Research, Inc.		Cincinnati	Ohio	45242	United States