Implications of Pacifier Use in Israeli Children

Drooling Clinical Trial

Official title:

Observational Study - Pacifier Use in Israeli Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01249885
• Other study ID #: 112010hmo-ctil
• Status: Not yet recruiting
• Phase: N/A
• First received: November 28, 2010
• Last updated: November 29, 2010
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2010
• Source: Hadassah Medical Organization
• Contact: Hadas Katz-Sagi, DMD
• Phone: 972 2 67778326
• Email: hadaskatzsagi[@]gmai.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Crossbite
• Drooling
• Openbite

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization, Jerusalem, Israel	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel,