Implications of Pacifier Use in Israeli Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hadassah Medical Organization.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Hadassah Medical Organization
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01249885
First received: November 28, 2010
Last updated: November 29, 2010
Last verified: November 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) |
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.
Eligibility| Ages Eligible for Study: | 2 Years to 5 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Hadas Katz-Sagi, DMD, Hadassah Medical Center |
| ClinicalTrials.gov Identifier: | NCT01249885 History of Changes |
| Other Study ID Numbers: | 112010hmo-ctil |
| Study First Received: | November 28, 2010 |
| Last Updated: | November 29, 2010 |
| Health Authority: | Israel: Ministry of Health |
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 |
ClinicalTrials.gov processed this record on May 21, 2013