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

NCT ID: NCT03771443

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-21
• Study Completion Date: 2020-01-21

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

Conditions

Gluten Sensitivity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

gluten free toothpaste

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

Group Type: EXPERIMENTAL

experimental gluten free toothpaste

Intervention Type: 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 .

Interventions

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 .

Intervention Type: DRUG

Other Intervention Names

natural toothpaste

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Eman Adel Abd Elhameed

master degree student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman A Abdelhameed, BSc

Role: PRINCIPAL_INVESTIGATOR

Resident at Pediatric Dentistry and Dental Public Health Department

Fatma KI Abdelgawad, PhD

Role: STUDY_CHAIR

Assistant Professor at Pediatric Dentistry and Dental Public Health Department

Kamal M El Motayam, PhD

Role: STUDY_DIRECTOR

Emeritus Professor at Pediatric Dentistry and Dental Public Health Department

Locations

Faculty of Dentistry, Cairo University

Giza, Al Manial, Cairo, Egypt, Egypt

Countries

Egypt

Other Identifiers

CEBD-CU-2018-12-01

Identifier Type: -

Identifier Source: org_study_id