- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01129908
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- celiac disease
Exclusion Criteria:
- no other systemic condition
- age 3-18
- children on medication
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- odelia- HMO-CTIL
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