Implications of Pacifier Use in Israeli Children

November 29, 2010 updated by: Hadassah Medical Organization

Observational Study - Pacifier Use in Israeli Children

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah Medical Organization, Jerusalem, Israel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Diana Ram, DMD
        • Principal Investigator:
          • Hadas Katz-Sagi, DMD
        • Sub-Investigator:
          • Liron Zilberstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

400 children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Investigators

  • Principal Investigator: Hadas Katz-Sagi, DMD, Hadassah MO
  • Study Director: Diana Ram, DMD, Hadassah MO

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

November 28, 2010

First Submitted That Met QC Criteria

November 29, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 29, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 112010hmo-ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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