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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.
production of an experimental gluten free toothpaste and providing it for children with celiac disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gluten free toothpaste | Experimental | experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental gluten free toothpaste | Drug | we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market . |
| Measure | Description | Time Frame |
|---|---|---|
| Ulcerative events | Reporting from the parent (Yes or No) | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation or ulceration | visual (Yes or No) | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eman A Abdelhameed, BSc | Resident at Pediatric Dentistry and Dental Public Health Department | Principal Investigator |
| Fatma KI Abdelgawad, PhD | Assistant Professor at Pediatric Dentistry and Dental Public Health Department | Study Chair |
| Kamal M El Motayam, PhD | Emeritus Professor at Pediatric Dentistry and Dental Public Health Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Giza | Al Manial, Cairo, Egypt | 11562 | Egypt |
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| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| C535886 | Jones syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C432564 | green tea bioflavonoid, zinc ascorbate-containing toothpaste |
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|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |