Implications of Pacifier Use in Israeli Children
Recruitment status was Not yet recruiting
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.
|Official Title:||Observational Study - Pacifier Use in Israeli Children|
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|