NCT02409836

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 1993

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1993

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1993

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 1993

Completed
21.7 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

March 24, 2015

Last Update Submit

April 1, 2015

Conditions

Healthy Individuals

Outcome Measures

Primary Outcomes (1)

  • Level of dentifrice ingested and used by various age groups of children.

    10 weeks

Secondary Outcomes (1)

  • Dentifrice ingestion amount as a function of dentifrice flavor and age of participants.

    10 weeks

Study Arms (3)

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

Marketed DentifriceDRUG

Marketed Dentifrice

Crest Cavity Protection
Marketed Flavored DentifriceDRUG

Hawaiian Punch Flavored

Crest for Kids Hawaiian Punch Paste

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hill Top Research, Inc.

Cincinnati, Ohio, 45242, United States

Location

Study Officials

  • John E Wild

    HIlltop Research Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2015

First Posted

April 7, 2015

Study Start

May 1, 1993

Primary Completion

July 1, 1993

Study Completion

July 1, 1993

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(1)