Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT01129908
Status:
COMPLETED
Last Update Posted:
2016-12-20
First Post:
2010-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-18', 'studyFirstSubmitDate': '2010-05-23', 'studyFirstSubmitQcDate': '2010-05-24', 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['oral health in children with celiac disease'], 'conditions': ['Celiac Disease']}, 'descriptionModule': {'briefSummary': "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.\n\nIn the oral environment the investigators see enamel defects and recurrent ulcers.\n\nCeliac 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).\n\nIt has been assumed that the patients have less cariogenic diet, and that caries prevalence is not as high as in normal population.\n\nIn 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.\n\nThese defects were found in 42.2% of celiac patients in appose to only 5.4% in healthy population.\n\nRecurrent ulcers were found in 41% in the oral cavity of celiac patients, compare to 27% in healthy population.\n\nAfter changing the diet to a gluten-free diet, an improvement is seen in the presence of these ulcers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'chilren with celiac disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* celiac disease\n\nExclusion Criteria:\n\n* no other systemic condition\n* age 3-18\n* children on medication'}, 'identificationModule': {'nctId': 'NCT01129908', 'briefTitle': 'Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet', 'orgStudyIdInfo': {'id': 'odelia- HMO-CTIL'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Senior Lecturer', 'investigatorFullName': 'Moti Moskovitz', 'investigatorAffiliation': 'Hadassah Medical Organization'}}}}