Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease

Study Overview
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Brief Summary
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Celiac disease (CD) is the most common genetically based food intolerance in the world, with a prevalence among approximately 1% of the general population (Guandalini & Assiri, 2014). CD is a frequent disorder among Egyptian children, both in the general population and in at-risk groups(Abu-Zekry et al., 2008). It is estimated that the incidence of CD is 3 to13 cases per1000, with a higher prevalence among first-degree relatives of patients with CD.Lifelong adherence to a strict gluten free diet (GFD) remains the only available treatment for patients with CD and typically results in a complete return to health. Nevertheless, gluten is not found only in diet, Gluten is commonly used as a binder in products like medication, cosmetics, oral and skin care, and even children's toys. Gluten is found also in toothpastes and other oral health products and it can be swallowed by mistake and initiate immune response(Anon, n.d.). Unfortunately, there is no gluten free toothpaste available in the Egyptian market and it is very expensive if we bought it from Europe or USA. The tube will cost nearly 10 dolars .As a result, the production and availability of gluten free toothpaste in Egypt has become mandatory.

Detailed Description
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production of an experimental gluten free toothpaste and providing it for children with celiac disease

Official Title
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Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)

Conditions
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Gluten Sensitivity

Intervention / Treatment
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* Drug: experimental gluten free toothpaste


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 6 yeas. Erupting lower 6. Can spit the toothpaste. Diagnosed as a celiac patient(pathology&serology) Exclusion Criteria: With a history of allergy to any ingredient present in the toothpaste to be used for treatment The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc. Children whose parents had no home or mobile phone to enable post-operative contact. Parent that will not sign the consent.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gluten free toothpaste<br>experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months | Drug: experimental gluten free toothpaste<br>* we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .<br>* Other names: natural toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcerative events | Reporting from the parent (Yes or No) | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation or ulceration | visual (Yes or No) | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gluten-free toothpaste,celiac disease, GFD, children