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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 15 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age above 6 yeas. 2. Erupting lower 6. 3. Can spit the toothpaste. 4. Diagnosed as a celiac patient.

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03771443
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Cairo University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Eman A Abdelhameed, BScFatma KI Abdelgawad, PhDKamal M El Motayam, PhD
Principal Investigator Affiliation Resident at Pediatric Dentistry and Dental Public Health DepartmentAssistant Professor at Pediatric Dentistry and Dental Public Health DepartmentEmeritus Professor at Pediatric Dentistry and Dental Public Health Department
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gluten Sensitivity
Additional Details

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

Contact a Trial Team

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International Sites

Faculty of Dentistry, Cairo University, Giza, Al Manial, Cairo, Egypt, Egypt

Status

Not yet recruiting

Address

Faculty of Dentistry, Cairo University

Giza, Al Manial, Cairo, Egypt, 11562

Site Contact

Eman A Abdelhameed, BSc

eman.adel@dentistry.cu.edu.eg

00201128029399

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