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Completed

NCT Number: NCT03771443

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

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.

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Key information

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Dentistry, Cairo University

Giza, Al Manial, Cairo, Egypt, 11562, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 6 yeas.
  • Erupting lower 6.
  • Can spit the toothpaste.
  • Diagnosed as a celiac patient(pathology&serology)

Exclusion criteria

  • With a history of allergy to any ingredient present in the toothpaste to be used for treatment
  • The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
  • Children whose parents had no home or mobile phone to enable post-operative contact.
  • Parent that will not sign the consent.

Treatment and study plan

experimental gluten free toothpaste

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 .

Other names: natural toothpaste

Primary outcomes

  1. Ulcerative events

    Time frame: Six months

    Reporting from the parent (Yes or No)

Secondary outcomes

  1. Inflammation or ulceration

    Time frame: six months

    visual (Yes or No)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2018
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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