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

Gluten Sensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771443
• Other study ID #: CEBD-CU-2018-12-01
• Status: Completed
• Phase: Phase 3
• Start date: July 21, 2019
• Est. completion date: January 21, 2020

Study information

• Verified date: July 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 21, 2020
• Est. primary completion date: January 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Age above 6 yeas.

2. Erupting lower 6.

3. Can spit the toothpaste.

4. Diagnosed as a celiac patient(pathology&serology)

Exclusion Criteria:

1. With a history of allergy to any ingredient present in the toothpaste to be used for treatment

2. The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.

3. Children whose parents had no home or mobile phone to enable post-operative contact.

4. Parent that will not sign the consent.

Related Conditions & MeSH terms

• Celiac Disease
• Gluten Sensitivity

Intervention

Drug:
• experimental gluten free toothpaste
we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Cairo University	Giza	Al Manial, Cairo, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcerative events	Reporting from the parent (Yes or No)	Six months
Secondary	Inflammation or ulceration	visual (Yes or No)	six months