Implications of Pacifier Use in Israeli Children | NCT01249885

Studies
Implications of Pacifier Use in Israeli Children

NCT01249885

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Nov 30, 2010Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Crossbite
Openbite
Drooling

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Jan 2012Estimated

Completion Date

Jan 2013Estimated

First Submitted Date

Nov 28, 2010

First Submission Date that Met QC Criteria

Nov 29, 2010

First Posted Date

Nov 30, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2010

Last Update Posted Date

Nov 30, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

400 children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hadas Katz-Sagi, DMD	Contact	972 2 67778326		hadaskatzsagi@gmai.com
Hadas Lemberg, PhD	Contact	972 2 6777572		lhadas@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Hadas Katz-Sagi, DMD	Hadassah MO	Principal Investigator
Diana Ram, DMD	Hadassah MO	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization, Jerusalem, Israel		Jerusalem		91120	Israel

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion
D024343	Open Bite
D012798	Sialorrhea
D001733	Bites and Stings

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D012466	Salivary Gland Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided