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Implications of Pacifier Use in Israeli Children

Primary Purpose

Crossbite, Openbite, Drooling

Status
Unknown status
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Crossbite focused on measuring pacifier sucking, children, occlusion, drooling

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hadassah Medical Organization, Jerusalem, Israel

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 28, 2010
Last Updated
November 29, 2010
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01249885
Brief Title
Implications of Pacifier Use in Israeli Children
Official Title
Observational Study - Pacifier Use in Israeli Children
Study Type
Observational

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
January 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Pacifier study protocol The study will take place in children day care centers in Jerusalem and "HaSharon" area. First step = Receiving an approval from the Children's parents and the day care management for the research. Next step = Examine a total of 400 children who use a pacifier, with a dental mirror in regular lighting condition. The procedure is short, no need of repetition or tracing and without any side effects or discomfort. Part 1- a short questionnaire of demographic background- will be answered by the parents: Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father…) Social economic status - mother's education, place of residence, number of children in the family. Child's personal details -gender, age, number of siblings Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier. Child's Dental condition- drooling, cross bite, open bite. Parents' Awareness of pacifier's effect on mouth development. Parents' approval for child examination. Part 2- clinical- visual examination for identification of relevant findings 1. Child's pacifier type. 2. Dental clinical examination performed in a lightened room: Diagnosis of caries- data will be written in a chart. Diagnosis of malocclusion- open bite or cross bite 3. Diagnosis of drooling from mouth corners which indicates malocclusion. Redness or dryness around lips and chin can imply drooling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crossbite, Openbite, Drooling
Keywords
pacifier sucking, children, occlusion, drooling

7. Study Design

Enrollment
400 (Anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy children aged 3-4 years that use a pacifier Exclusion Criteria: 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
Study Population Description
400 children
Sampling Method
Non-Probability Sample
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Katz-Sagi, DMD
Phone
972 2 67778326
Email
hadaskatzsagi@gmai.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hadas Lemberg, PhD
Phone
972 2 6777572
Email
lhadas@hadassah.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadas Katz-Sagi, DMD
Organizational Affiliation
Hadassah MO
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Diana Ram, DMD
Organizational Affiliation
Hadassah MO
Official's Role
Study Director
Facility Information:
Facility Name
Hadassah Medical Organization, Jerusalem, Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Diana Ram, DMD
First Name & Middle Initial & Last Name & Degree
Hadas Katz-Sagi, DMD
First Name & Middle Initial & Last Name & Degree
Liron Zilberstein

12. IPD Sharing Statement

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Implications of Pacifier Use in Israeli Children

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