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

NCT03771443 | Completed Phase 3

• 1 other identifier: CEBD-CU-2018-12-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Gluten Sensitivity

Keywords

Gluten-free toothpaste,celiac disease, GFD, children

Outcome Measures

Primary Outcomes (1)

• Ulcerative events

  Reporting from the parent (Yes or No)

  Six months

Secondary Outcomes (1)

• Inflammation or ulceration

  six months

Study Arms (1)

gluten free toothpaste

EXPERIMENTAL

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

Interventions

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 .

Also known as: natural toothpaste

gluten free toothpaste

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

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

Location

MeSH Terms

Conditions

Celiac Disease; Jones syndrome

Interventions

green tea bioflavonoid, zinc ascorbate-containing toothpaste

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eman A Abdelhameed, BSc

  Resident at Pediatric Dentistry and Dental Public Health Department

  PRINCIPAL INVESTIGATOR

• Fatma KI Abdelgawad, PhD

  Assistant Professor at Pediatric Dentistry and Dental Public Health Department

  STUDY CHAIR

• Kamal M El Motayam, PhD

  Emeritus Professor at Pediatric Dentistry and Dental Public Health Department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master degree student

Study Record Dates

• First Submitted: December 8, 2018
• First Posted: December 11, 2018
• Study Start: July 21, 2019
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: July 21, 2020

Record last verified: 2020-07

Locations

EG (1)