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

Phase 3

Completed

• Conditions: Gluten Sensitivity
• Interventions: Drug: experimental gluten free toothpaste

• Registration Number: NCT03771443
• Lead Sponsor: Cairo University

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2018-12-08
• Study First Submitted QC: 2018-12-08
• Study First Posted: 2018-12-11
• Study Start: 2019-07-21
• Primary Completion: 2020-01-21
• Study Completion: 2020-01-21
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-18
• Last Update Posted: 2020-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gluten free toothpaste	experimental gluten free toothpaste	experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months

Primary Outcome Measures

Name	Time	Method
Ulcerative events	Six months	Reporting from the parent (Yes or No)

Secondary Outcome Measures

Name	Time	Method
Inflammation or ulceration	six months	visual (Yes or No)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Giza, Al Manial, Cairo, Egypt, Egypt