Implications of Pacifier Use in Israeli Children
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|ClinicalTrials.gov Identifier: NCT01249885|
Recruitment Status : Unknown
Verified November 2010 by Hadassah Medical Organization.
Recruitment status was: Not yet recruiting
First Posted : November 30, 2010
Last Update Posted : November 30, 2010
|Condition or disease|
|Crossbite Openbite Drooling|
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:
- Personal details- Parents names and ages, child's name and ID number, relation to the child (mother, father…)
- Social economic status - mother's education, place of residence, number of children in the family.
- Child's personal details -gender, age, number of siblings
- Pacifier use habits- period of use, type of pacifier, frequency of use, reason of using a pacifier.
- Child's Dental condition- drooling, cross bite, open bite.
- Parents' Awareness of pacifier's effect on mouth development.
- 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|
|Estimated Enrollment :||400 participants|
|Official Title:||Observational Study - Pacifier Use in Israeli Children|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2012|
|Estimated Study Completion Date :||January 2013|
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
|Contact: Hadas Katz-Sagi, DMD||972 2 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD||972 2 email@example.com|
|Hadassah Medical Organization, Jerusalem, Israel||Not yet recruiting|
|Jerusalem, Israel, 91120|
|Contact: Arik Tzukert, DMD 972 2 6776095 firstname.lastname@example.org|
|Contact: Hadas Lemberg, PhD 972 2 6777572 email@example.com|
|Sub-Investigator: Diana Ram, DMD|
|Principal Investigator: Hadas Katz-Sagi, DMD|
|Sub-Investigator: Liron Zilberstein|
|Principal Investigator:||Hadas Katz-Sagi, DMD||Hadassah MO|
|Study Director:||Diana Ram, DMD||Hadassah MO|