NCT01249885

Brief Summary

The purpose of this study is to examine pacifier sucking habits among children, and to assess implications of the oral habit - for example malocclusions and drooling. The effect of pacifier sucking will be recorded and compared to pacifier type and frequency of use.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 28, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

November 28, 2010

Last Update Submit

November 29, 2010

Conditions

CrossbiteOpenbiteDrooling

Keywords

pacifier suckingchildrenocclusiondrooling

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

400 children

You may qualify if:

  • healthy children aged 3-4 years that use a pacifier

You may not qualify if:

  • children suffering from a chronic or developmental disease that can affect the orofacial region
  • finger sucking children children suffering from low muscle tonus, abnormal drooling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

MalocclusionOpen BiteSialorrheaBites and Stings

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSalivary Gland DiseasesMouth DiseasesPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Hadas Katz-Sagi, DMD

    Hadassah MO

    PRINCIPAL INVESTIGATOR

  • Diana Ram, DMD

    Hadassah MO

    STUDY DIRECTOR

Central Study Contacts

Hadas Katz-Sagi, DMD

CONTACT

972 2 67778326hadaskatzsagi@gmai.com

Hadas Lemberg, PhD

CONTACT

972 2 6777572lhadas@hadassah.org.il

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 28, 2010

First Posted

November 30, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2013

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations

IL(1)