Celiac DiseaseNCT01129908
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
An observational study of Celiac Disease, run by Hadassah Medical Organization.
Trial summary
The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food. In the oral environment the investigators see enamel defects and recurrent ulcers. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Celiac Disease
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Jul 2012
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: chilren with celiac disease
Who may be able to join
- celiac disease
Who cannot join
- no other systemic condition
- age 3-18
- children on medication
About this study
The celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.
In the oral environment the investigators see enamel defects and recurrent ulcers.
Read more
Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss).
It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.
In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic.
These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.
Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.
After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.
- Conditions
- Celiac Disease
- Keywords
- oral health in children with celiac disease
- Medical subject headings
- Celiac Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moti Moskovitz, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129908
- Sponsor's protocol ID
- odelia- HMO-CTIL
- Status last verified
- Dec 2016
- First submitted
- 23 May 2010
- Last updated
- 20 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
- ClinicalTrials.gov ID
- NCT01129908
- Acronym / sponsor ID
- odelia- HMO-CTIL
- Conditions
- Celiac Disease
- Keywords
- oral health in children with celiac disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 25 May 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 celiac disease (CD) is a disease with an immune and genetic component that is activated by the presence of gluten, and damages the intestine mucosa and causes malabsorption of food.
In the oral environment the investigators see enamel defects and recurrent ulcers.
Celiac patients have to keep a restrict gluten-free diet, in order to prevent the clinical symptoms of the disease (such as diarrhea, stomach ache and weight loss).
It has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.
In celiac patients the investigators find enamel defects that are characterized with pits and deep fissures and sometimes the complete loss of enamel. These defects are classified by the grading of the CD related DED's (dental enamel defects) according to Aine. These defects are symmetrical defects in the permanent dentition, in teeth that develops at the same time. The cause is thought to be hypocalcaemia or genetic.
These defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.
Recurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.
After changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- chilren with celiac disease
Key inclusion criteria (1 listed)
- celiac disease
Key exclusion criteria (3 listed)
- no other systemic condition
- age 3-18
- children on medication
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Hadassah Medical Organization.
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 3 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: finished, as of the sponsor's last update on 20 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 20 Dec 2016.