Implications of Pacifier Use in Israeli Children

• Conditions: Crossbite; Openbite; Drooling

• Registration Number: NCT01249885
• Lead Sponsor: Hadassah Medical Organization

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:

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.

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-28
• Study First Submitted QC: 2010-11-29
• Last Update Submitted: 2010-11-29
• Study First Posted: 2010-11-30
• Last Update Posted: 2010-11-30
• Study Start: 2011-01
• Primary Completion: 2012-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Hadassah Medical Organization, Jerusalem, Israel; 🇮🇱 Jerusalem, Israel