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Trial registered on ANZCTR


Registration number
ACTRN12622000403730
Ethics application status
Approved
Date submitted
24/02/2022
Date registered
9/03/2022
Date last updated
2/05/2023
Date data sharing statement initially provided
9/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the prevalence of Coeliac disease in children with Developmental Defects of Enamel
Scientific title
Evaluating the prevalence of Coeliac disease in children with Developmental Defects of Enamel
Secondary ID [1] 306481 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coeliac Disease
 325339 0
Dental Caries 325340 0
Condition category
Condition code
Inflammatory and Immune System 322723 322723 0 0
Autoimmune diseases
Diet and Nutrition 322724 322724 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 322725 322725 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.
Intervention code [1] 322950 0
Diagnosis / Prognosis
Comparator / control treatment
There will be 50 control participants, who have not been diagnosed with dental defects of enamel. or Coeliac disease.
Control group
Active

Outcomes
Primary outcome [1] 330578 0
Positive and negative diagnostic value of a point of care blood test (Simtomax kit) for coeliac disease in children with dental developmental defects of enamel.

Coeliac disease is diagnosed by positive blood tests for transglutaminase-IgA (tTG-IgA) and deamidated peptide-IgG (DGP-IgG), or tTG-IgA and total IgA along with confirmatory gastroscopy and small intestinal biopsy. Hence children who have a positive point of care test will be referred to their GP for further testing and/or to a paediatric gastroenterologist.
Timepoint [1] 330578 0
Screening/Baseline
Secondary outcome [1] 406758 0
Retrospective analysis of coeliac disease symptoms (if any) using a patient reported outcomes of coeliac disease survey (designed specifically for this study)
Timepoint [1] 406758 0
Baseline
Secondary outcome [2] 407128 0
Predictive value of the number and severity of developmental defects of enamel in children with coeliac disease, assessed by a qualified paediatric dentist using the DDE index.
Timepoint [2] 407128 0
Baseline

Eligibility
Key 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.
Minimum age
2 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Descriptive statistics and non-parametric statistical tests will be used. Sample size is empirical.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 310828 0
Other
Name [1] 310828 0
Wesley Research Institute Ltd
Country [1] 310828 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Coeliac Australia
Address
Suite 1
41-45 Pacific Highway
Waitara NSW 2077
Country
Australia
Secondary sponsor category [1] 312077 0
Other
Name [1] 312077 0
Wesley Research Institute Ltd
Address [1] 312077 0
Level 8 East Wing
The Wesley Hospital
451 Coronation Dr
Auchenflower
Qld 4066
Country [1] 312077 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310392 0
Bellberry Ltd
Ethics committee address [1] 310392 0
Ethics committee country [1] 310392 0
Australia
Date submitted for ethics approval [1] 310392 0
22/02/2022
Approval date [1] 310392 0
04/05/2022
Ethics approval number [1] 310392 0
2022-02-150

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117498 0
Dr James Daveson
Address 117498 0
Level 8 East Wing
The Wesley Hospital
451 Coronation Dr
Auchenflower, QLD 4066
Country 117498 0
Australia
Phone 117498 0
+61 1800363677
Fax 117498 0
Email 117498 0
james.daveson@endosq.com
Contact person for public queries
Name 117499 0
James Daveson
Address 117499 0
Level 8 East Wing
The Wesley Hospital
451 Coronation Dr
Auchenflower, QLD 4066
Country 117499 0
Australia
Phone 117499 0
+61 1800 363 677
Fax 117499 0
Email 117499 0
james.daveson@endosq.com
Contact person for scientific queries
Name 117500 0
James Daveson
Address 117500 0
Level 8 East Wing (The Wesley Hospital)
451 Coronation Dr
Auchenflower, QLD 4066
Country 117500 0
Australia
Phone 117500 0
+61 1800 363 677
Fax 117500 0
Email 117500 0
james.daveson@endosq.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.