Back to resultsAssessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
Primary Purpose
Gluten Sensitivity
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
experimental gluten free toothpaste
Sponsored by
About this trial
This is an interventional prevention trial for Gluten Sensitivity focused on measuring Gluten-free toothpaste,celiac disease, GFD, children
Eligibility Criteria
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.
Sites / Locations
- Faculty of Dentistry, Cairo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gluten free toothpaste
Arm Description
experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months
Outcomes
Primary Outcome Measures
Ulcerative events
Reporting from the parent (Yes or No)
Secondary Outcome Measures
Inflammation or ulceration
visual (Yes or No)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03771443
Brief Title
Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
Official Title
Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease (Before and After Pilot Study)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 21, 2019 (Actual)
Primary Completion Date
January 21, 2020 (Actual)
Study Completion Date
January 21, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gluten Sensitivity
Keywords
Gluten-free toothpaste,celiac disease, GFD, children
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
gluten free toothpaste
Arm Type
Experimental
Arm Description
experimental gluten free toothpaste with natural ingredients prepared for the study to be used 3 times per day for six months
Intervention Type
Drug
Intervention Name(s)
experimental gluten free toothpaste
Other Intervention Name(s)
natural toothpaste
Intervention Description
we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .
Primary Outcome Measure Information:
Title
Ulcerative events
Description
Reporting from the parent (Yes or No)
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Inflammation or ulceration
Description
visual (Yes or No)
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman A Abdelhameed, BSc
Organizational Affiliation
Resident at Pediatric Dentistry and Dental Public Health Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fatma KI Abdelgawad, PhD
Organizational Affiliation
Assistant Professor at Pediatric Dentistry and Dental Public Health Department
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kamal M El Motayam, PhD
Organizational Affiliation
Emeritus Professor at Pediatric Dentistry and Dental Public Health Department
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Giza
State/Province
Al Manial, Cairo, Egypt
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Assessment of the Effect of Gluten Free Toothpaste on the Ulcerative Events in Children With Celiac Disease
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