None listed
Conditions
Brief summary
Undiagnosed or unrecognised Coeliac disease is associated with a 3-fold increased risk of autoimmune disease (such as type 1 diabetes), osteoporosis and malignancy (such as lymphoma), decreased quality of life and a 2 to 4-fold increase in mortality. Early diagnosis and treatment of Coeliac disease reduces or avoids many of these complications and reduces health care expenditure. In Australia it is estimated that Coeliac disease affects 1 in 60 females and 1 in 80 males based on serological testing. Despite this, the rate of diagnosis through routine medical care is very low, resulting in 4 out of 5 Australians with Coeliac disease remaining undiagnosed. There is currently insufficient data to support population-wide screening for Coeliac disease. As such, screening is based on active case finding of high-risk individuals, such as first-degree relatives of Coeliac disease sufferers and other high-risk populations such as those with developmental defects of enamel in the teeth. Coeliac disease is known to be associated with dental developmental defects of enamel in children. They appear as bilateral, symmetrical and chronologic white or yellow opacities with or without grooves and structural defects. It is thought to be caused by an immune mediated reaction affecting the cells that form enamel and possible nutritional disturbances. Delayed diagnosis and increased exposure to gluten is likely to result in more significant enamel defects over time. Therefore, screening for Coeliac disease in high-risk individuals with developmental defects of enamel could decrease the amount of future enamel and structural defects. This research study is a prospective exploratory study which aims to assess how many children with developmental defects of enamel have undiagnosed Coeliac disease . The study is being conducted at the Paediatric Dental Group, Wesley Medical Research (WMR) and St Andrew’s War Memorial Hospital (SAWMH) in Brisbane, Australia
Interventions
This research study is a prospective exploratory study which aims to assess how many children with dental developmental defects of enamel have undiagnosed Coeliac Disease. The study will enrol a total of 300 participants over a six-month period, with a minimum of 250 participants with enamel defects and 50 control participants without enamel defects.
At the potential participants routine dental visit a paediatric dentist will examine the participant's teeth for the presence of developmental de
This research study is a prospective exploratory study which aims to assess how many children with dental developmental defects of enamel have undiagnosed Coeliac Disease. The study will enrol a total of 300 participants over a six-month period, with a minimum of 250 participants with enamel defects and 50 control participants without enamel defects. At the potential participants routine dental visit a paediatric dentist will examine the participant's teeth for the presence of developmental defects of enamel. If developmental defects of enamel are present the dentist will record the number of teeth affected and classify the severity of developmental defects of enamel according to an internationally accepted classification at this initial appointment, which will take approximately 30min to complete. Whether or not developmental defects of enamel are present the dentist will discuss the study with the the potential participant and if they are interested the participant's parent/legal guardian will be asked to provide written informed consent. The participant may also be invited to provide written informed consent if they wish to. During the initial dental appointment or at a follow-up appointment for the participant's scheduled dental treatment, the following tests, procedures and data collection will be performed, this should take approximately 1-2 hours to complete; 1. A medical examination including medical and surgical history, height, and weight.? 2. Documentation of demographic information (DOB, age, race and gender).? 3. Completion of a Patient Reported Outcome survey to determine whether the participant experiences any symptoms related to a possible intolerance of gluten. 4. Documentation of medication history for the three months prior to the visit. 5. Confirmation that the participant does not have a diagnosis of coeliac disease. 6. Documentation of medical history including any disease or disorder affecting any body system.? 7. Confirmation that the participant is on a gluten-containing diet (i.e. equivalent to at least 4 slices of bread per day or at least one gluten containing meal per day) for the previous 6 months before study enrolment.? 8. Collection of a small sample of the participants blood (approximately 0.02ml) by finger prick to test for CD-specific antibodies using the POCT.? The POCT being used in the study is the Simtomax® (Augurix Diagnostics) kit, which measures total IgA, DGP-IgG and DGP-IgA. The result will be read independently at 10 minutes by the dentist and again by a dental assistant/nurse or study coordinator. Participants will be notified of their result as soon as it is available (within 10-20min) and if positive they will be referred to their GP and a paediatric gastroenterologist for further testing and follow-up.
Sponsors
Coeliac Australia
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
1) Subjects greater than or equal to two (2) years of age, though less than or equal to 18 with/without developmental defects of enamel identified at the time of a dental review. 2) The subject or their guardian (if under 16 years of age) understands and agrees to the informed consent form (ICF). 3) Consuming gluten in their diet on a daily basis, at no less than four pieces of bread per day, or at least one gluten containing meal per day.
Exclusion criteria
1) Subject has been on a strict gluten free diet or limiting gluten for more than month prior to recruitment. 2) Subject is or has been using an immune-modulatory or immune suppressive therapy during the six months prior to recruitment. 3) Subject has received oral or parenteral corticosteroids within the previous 8 weeks prior to recruitment. Topical or inhaled corticosteroids are acceptable. 4) Unable to provide written informed consent. 5) Unwilling to undergo a pin-prick test.
Outcome results
None listed