CrossbiteNCT01249885
Implications of Pacifier Use in Israeli Children
An observational study of Crossbite and Openbite, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 400 children
Who may be able to join
- healthy children aged 3-4 years that use a pacifier
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization, Jerusalem, Israel
Jerusalem, 91120
Arik Tzukert, DMD, 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Observational Study - Pacifier Use in Israeli Children
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.
Read the 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
- 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.
- Keywords
- pacifier sucking, children, occlusion, drooling
- Medical subject headings
- Malocclusion, Open Bite, Sialorrhea, Bites and Stings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CrossbiteStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Hadas Katz-Sagi, DMD, Principal investigator, Hadassah MODiana Ram, DMD, Study director, Hadassah MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249885
- Sponsor's protocol ID
- 112010hmo-ctil
- Status last verified
- Nov 2010
- First submitted
- 28 Nov 2010
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study - Pacifier Use in Israeli Children
- ClinicalTrials.gov ID
- NCT01249885
- Acronym / sponsor ID
- 112010hmo-ctil
- Keywords
- pacifier sucking, children, occlusion, drooling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 400 children
Key inclusion criteria (1 listed)
- healthy children aged 3-4 years that use a pacifier
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadas Katz-Sagi, DMD principal investigator
Hadassah MO
Diana Ram, DMD study director
Hadassah MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crossbite and Openbite, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hadas Katz-Sagi, DMD (972 2 67778326, hadaskatzsagi@gmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.