Clinical trial NCT03771443: Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
Official title: Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gluten Sensitivity
Keywords: Gluten-free toothpaste,celiac disease, GFD, children
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

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.

Primary outcomes:
measure: Ulcerative events
timeFrame: Six months
Secondary outcomes:
measure: Inflammation or ulceration
timeFrame: six months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: Al Manial, Cairo, Egypt
Study officials:
affiliation: Resident at Pediatric Dentistry and Dental Public Health Department
name: Eman A Abdelhameed, BSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor at Pediatric Dentistry and Dental Public Health Department
name: Fatma KI Abdelgawad, PhD
role: STUDY_CHAIR
affiliation: Emeritus Professor at Pediatric Dentistry and Dental Public Health Department
name: Kamal M El Motayam, PhD
role: STUDY_DIRECTOR
References: