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Implications of Pacifier Use in Israeli Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01249885
First Posted: November 30, 2010
Last Update Posted: November 30, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization
  Purpose
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.

Condition
Crossbite Openbite Drooling

Study Type: Observational
Official Title: Observational Study - Pacifier Use in Israeli Children

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 400
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
400 children
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249885


Contacts
Contact: Hadas Katz-Sagi, DMD 972 2 67778326 hadaskatzsagi@gmai.com
Contact: Hadas Lemberg, PhD 972 2 6777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization, Jerusalem, Israel Not yet recruiting
Jerusalem, Israel, 91120
Contact: Arik Tzukert, DMD    972 2 6776095    arik@hadassah.org.il   
Contact: Hadas Lemberg, PhD    972 2 6777572    lhadas@hadassah.org.il   
Sub-Investigator: Diana Ram, DMD         
Principal Investigator: Hadas Katz-Sagi, DMD         
Sub-Investigator: Liron Zilberstein         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Hadas Katz-Sagi, DMD Hadassah MO
Study Director: Diana Ram, DMD Hadassah MO
  More Information

Responsible Party: Hadas Katz-Sagi, DMD, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT01249885     History of Changes
Other Study ID Numbers: 112010hmo-ctil
First Submitted: November 28, 2010
First Posted: November 30, 2010
Last Update Posted: November 30, 2010
Last Verified: November 2010

Keywords provided by Hadassah Medical Organization:
pacifier sucking
children
occlusion
drooling

Additional relevant MeSH terms:
Sialorrhea
Malocclusion
Open Bite
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases