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

NCT03771443 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-21

No results posted yet for this study

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.

Conditions

  • Gluten Sensitivity

Interventions

DRUG

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 .

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Eman A Abdelhameed, BSc · Resident at Pediatric Dentistry and Dental Public Health Department

  • Fatma KI Abdelgawad, PhD · Assistant Professor at Pediatric Dentistry and Dental Public Health Department

  • Kamal M El Motayam, PhD · Emeritus Professor at Pediatric Dentistry and Dental Public Health Department

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-21
Primary Completion
2020-01-21
Completion
2020-01-21

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771443 on ClinicalTrials.gov