Implications of Pacifier Use in Israeli Children

NCT ID: NCT01249885

Last Updated: 2010-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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:

1. Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father…)
2. Social economic status - mother's education, place of residence, number of children in the family.
3. Child's personal details -gender, age, number of siblings
4. Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier.
5. Child's Dental condition- drooling, cross bite, open bite.
6. Parents' Awareness of pacifier's effect on mouth development.
7. 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.

Conditions

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Crossbite Openbite Drooling

Keywords

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pacifier sucking children occlusion drooling

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Hadassah Medical Center

Principal Investigators

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Hadas Katz-Sagi, DMD

Role: PRINCIPAL_INVESTIGATOR

Hadassah MO

Diana Ram, DMD

Role: STUDY_DIRECTOR

Hadassah MO

Locations

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Hadassah Medical Organization, Jerusalem, Israel

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Hadas Katz-Sagi, DMD

Role: CONTACT

Phone: 972 2 67778326

Email: [email protected]

Hadas Lemberg, PhD

Role: CONTACT

Phone: 972 2 6777572

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

Other Identifiers

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112010hmo-ctil

Identifier Type: -

Identifier Source: org_study_id