NCT01129908

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 20, 2016

Status Verified

December 1, 2016

Enrollment Period

2.2 years

First QC Date

May 23, 2010

Last Update Submit

December 18, 2016

Conditions

Keywords

oral health in children with celiac disease

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

chilren with celiac disease

You may qualify if:

  • celiac disease

You may not qualify if:

  • no other systemic condition
  • age 3-18
  • children on medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Celiac Disease

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Senior Lecturer

Study Record Dates

First Submitted

May 23, 2010

First Posted

May 25, 2010

Study Start

May 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

December 20, 2016

Record last verified: 2016-12