Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet

Celiac Disease Clinical Trial

Official title:

Saliva Composition and Oral Hygiene in Children With Celiac Disease Before and After the Change in Diet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129908
• Other study ID #: odelia- HMO-CTIL
• Status: Completed
• Phase: N/A
• First received: May 23, 2010
• Last updated: December 18, 2016
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: December 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ministry of Health - Director General: Israel
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

• celiac disease

Exclusion Criteria:

• no other systemic condition

• age 3-18

• children on medication

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Celiac Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization