Implications of Pacifier Use in Israeli Children
Primary Purpose
Crossbite, Openbite, Drooling
Status
Unknown status
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Crossbite focused on measuring pacifier sucking, children, occlusion, drooling
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
Sites / Locations
- Hadassah Medical Organization, Jerusalem, Israel
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01249885
First Posted
November 28, 2010
Last Updated
November 29, 2010
Sponsor
Hadassah Medical Organization
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
Learn more about this trial
Implications of Pacifier Use in Israeli Children
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