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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03771443

Enrollment

Registered

2018-12-11

Start date

2019-07-21

Completion date

2020-01-21

Last updated

2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gluten Sensitivity

Keywords

Gluten-free toothpaste,celiac disease, GFD, children

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

Interventions

DRUGexperimental 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 .

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 15 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Ulcerative events	Six months	Reporting from the parent (Yes or No)

Secondary

Measure	Time frame	Description
Inflammation or ulceration	six months	visual (Yes or No)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026