Implications of Pacifier Use in Israeli Children
|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|
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|