Dental CariesNCT00867542
Dental and Oral Finding in Israeli Children With Past Intrauterine Growth Retardation (IUGR)
An observational study of Dental Caries, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
oral status and early childhood caries (ecc) in israeli children with past IUGR Read more about this study
- Who is it for?
- Ages 3 to 4 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Feb 2010
- 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 3 to 4 years
- Women only
- Healthy volunteers accepted
- Child
Study population: 15 children aged 3-4 y old with IUGR in the past, 30 healthy children sex and age matched
Who may be able to join
- children who were born and diagnosed with IUGR
Who cannot join
- children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, Jerusalem, 91120
Arik Tzukert, DMD, : 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, lhadas@hadassah.org.il
About this study
Official title: Dental and Oral Findings in Israeli Children With Past IUGR - a Comprehensive Study
oral status and early childhood caries (ecc) in israeli children with past IUGR
- Conditions
- Dental Caries
- Being tested
- no intervention
- Keywords
- past IUGR, ECC, oral findings in children with past IUGR
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called ECC, past IUGR
no intervention
| Study group | Role | What they receive |
|---|---|---|
| past IUGR | 3-4 y old children with past IUGR Receives: Other: no intervention | |
| control | 3-4 y old healthy children Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
oral status of children with past IUGR
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2009 (estimated)
- Study completionFeb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867542
- Sponsor's protocol ID
- iugr2009HMO-CTIL
- Status last verified
- Mar 2009
- First submitted
- 22 Mar 2009
- Last updated
- 24 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental and Oral Findings in Israeli Children With Past IUGR - a Comprehensive Study
- ClinicalTrials.gov ID
- NCT00867542
- Acronym / sponsor ID
- iugr2009HMO-CTIL
- Conditions
- Dental Caries
- Keywords
- past IUGR, ECC, oral findings in children with past IUGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Feb 2010 (estimated)
- First posted
- 24 Mar 2009 (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.
oral status and early childhood caries (ecc) in israeli children with past IUGR
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| past IUGR | – | Other: no intervention3-4 y old children with past IUGR |
| control | – | Other: no intervention3-4 y old healthy children |
Who may qualify
- Ages
- 3 to 4 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 15 children aged 3-4 y old with IUGR in the past, 30 healthy children sex and age matched
Key inclusion criteria (1 listed)
- children who were born and diagnosed with IUGR
Key exclusion criteria (1 listed)
- children whos mothers have been diagnosed with diabetes or high blood pressure children with genetic disorders multiple babies pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionAlso: ECC, past IUGRno intervention | Other | control, past IUGR |
Primary outcome
oral status of children with past IUGR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2009.
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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.
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 Dental Caries, 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 1 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 24 Mar 2009. 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 (97226776168, hadaskatzsagi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oral status of children with past IUGR (time frame: 1 year). It is what the study was designed to measure, not a finding.
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 24 Mar 2009.