Dental CariesNCT00334087
The Relation Between Pregnancy,Birth Outcome, Feeding , Oral Hygiene Habits and Early Childhood Caries Development.
An observational study of Dental Caries, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
200 children between ages 36 to 48 months will be invited for a regular dental examination Parameters to be investigated 1. Pregnancy history 2. Birth outcome 3. Child's general health 4. Feeding habits 5. Oral hygiene habits 6. Dmft caries index 7. Congenital enamel defects Read more about this study
- Who is it for?
- Ages 36 to 48 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- feeding habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2007to Sep 2007
- 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 36 to 48 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
Who cannot join
- children not born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization
Jerusalem, 91120
HADAS LEMBERG, PHD, 972 2 6776095, lhadas@hadassah.org.il
Itay Leizer, student
About this study
Official title: Assessment of Pregnancy History, Birth Outcome, Feeding and Oral Practices With Development of Early Childhood Caries in Offspring of Women Who Have Not Participated in Previous Birth Preparation Class
- 200 children between ages 36 to 48 months will be invited for a regular dental examination
- Parameters to be investigated
- Pregnancy history
- Birth outcome
- Child's general health
- Feeding habits
- Oral hygiene habits
- Dmft caries index
- Congenital enamel defects
Read the detailed description
Severe Early Childhood Caries is a condition whereby very young children suffer multiple caries. The value of a pre- perinatal preventive approach is currently being examined in the dental literature. At Hadassah, a Pilot Study is currently underway to test the feasibility of a comprehensive Baby Clinic designed to prevent Severe Early Childhood Caries. The pilot study in cooperation with the Woman's Health Center and with the midwives and the breastfeeding counselors of the maternity unit. Lectures are given by pediatric dentists to parents of firstborn children attending Hadassah's Birth Preparation Class, emphasis is given to the importance of breastfeeding and other feeding habits in the emotional, physical, nutritional and immunological development of the future baby. In addition the effect of these feeding habits on the dental/oral aspects, relevant for the developing dentition.
After birth the parents are invited to come with their babies around 12 months for the first dental examination and follow up according to individual risk for caries development. The current proposed study will be a control group from offspring of women who have participated previous Sessions Hadassah's Birth Preparation Class ("Historical Controls" before the Baby Clinic project)
- Conditions
- Dental Caries
- Being tested
- feeding habits
- Keywords
- primary dental prevention, early childhood caries, prenatal oral care
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
feeding habitsBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startJun 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Evelyn Mamber, DMD, Principal investigator, Hadassah Medical Organization IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00334087
- Sponsor's protocol ID
- boquita HMO-CTIL
- Status last verified
- Apr 2007
- First submitted
- 5 Jun 2006
- Last updated
- 17 Apr 2007
- Results posted
- No
Publications
Gomez SS, Weber AA. Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring. Int J Paediatr Dent. 2001 Mar;11(2):117-22. doi: 10.1046/j.1365-263x.2001.00255.x.
PubMed 11310134
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Pregnancy History, Birth Outcome, Feeding and Oral Practices With Development of Early Childhood Caries in Offspring of Women Who Have Not Participated in Previous Birth Preparation Class
- ClinicalTrials.gov ID
- NCT00334087
- Acronym / sponsor ID
- boquita HMO-CTIL
- Conditions
- Dental Caries
- Keywords
- primary dental prevention, early childhood caries, prenatal oral care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jun 2007
- Study completion
- Sep 2007
- First posted
- 6 Jun 2006 (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.
- 200 children between ages 36 to 48 months will be invited for a regular dental examination
- Parameters to be investigated
- Pregnancy history
- Birth outcome
- Child's general health
- Feeding habits
- Oral hygiene habits
- Dmft caries index
- Congenital enamel defects
Detailed description
Severe Early Childhood Caries is a condition whereby very young children suffer multiple caries. The value of a pre- perinatal preventive approach is currently being examined in the dental literature. At Hadassah, a Pilot Study is currently underway to test the feasibility of a comprehensive Baby Clinic designed to prevent Severe Early Childhood Caries. The pilot study in cooperation with the Woman's Health Center and with the midwives and the breastfeeding counselors of the maternity unit. Lectures are given by pediatric dentists to parents of firstborn children attending Hadassah's Birth Preparation Class, emphasis is given to the importance of breastfeeding and other feeding habits in the emotional, physical, nutritional and immunological development of the future baby. In addition the effect of these feeding habits on the dental/oral aspects, relevant for the developing dentition.
After birth the parents are invited to come with their babies around 12 months for the first dental examination and follow up according to individual risk for caries development. The current proposed study will be a control group from offspring of women who have participated previous Sessions Hadassah's Birth Preparation Class ("Historical Controls" before the Baby Clinic project)
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 36 to 48 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
Key exclusion criteria (1 listed)
- children not born in previous Sessions Hadassah's Birth Preparation Class " before the Baby Clinic project)
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 |
|---|---|---|
| feeding habits | Behavioural | – |
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 17 Apr 2007.
- Results publication: PubMed 11310134Gomez SS, Weber AA. Effectiveness of a caries preventive program in pregnant women and new mothers on their offspring. Int J Paediatr Dent. 2001 Mar;11(2):117-22. doi: 10.1046/j.1365-263x.2001.00255.x.
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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.
Evelyn Mamber, DMD principal investigator
Hadassah Medical Organization IRB
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 17 Apr 2007. 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 Evelyn Mamber, DMD (00 972 2 6723771, mamber@bezeqint.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00334087, which also lists 1 linked publication.
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 17 Apr 2007.