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)

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.

Study Overview

• Status: Completed
• Conditions: Gluten Sensitivity
• Intervention / Treatment: Drug: experimental gluten free toothpaste

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Al Manial, Cairo, Egypt
    • Giza, Al Manial, Cairo, Egypt, Egypt, 11562
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: gluten free toothpaste; experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months	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 .; Other Names: natural toothpaste

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Eman A Abdelhameed, BSc, Resident at pediatric Dentistry and Dental Public Health Department; Study Chair: Fatma KI Abdelgawad, PhD, Assistant Professor at Pediatric Dentistry and Dental Public Health Department; Study Director: Kamal M El Motayam, PhD, Emeritus Professor at Pediatric Dentistry and Dental Public Health Department

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2019
• Primary Completion (Actual): January 21, 2020
• Study Completion (Actual): January 21, 2020

Study Registration Dates

• First Submitted: December 8, 2018
• First Submitted That Met QC Criteria: December 8, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 21, 2020
• Last Update Submitted That Met QC Criteria: July 18, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Gluten-free toothpaste,celiac disease, GFD, children
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Gastrointestinal Diseases; Intestinal Diseases; Malabsorption Syndromes; Celiac Disease
• Other Study ID Numbers: CEBD-CU-2018-12-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No