Status:
COMPLETED
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Lead Sponsor:
Universitat Internacional de Catalunya
Conditions:
Aphthous Stomatitis
Eligibility:
All Genders
3-13 years
Phase:
NA
Brief Summary
The aim of the study was to assess the safety, acceptability, and efficacy of product GV-328 for the treatment of childhood oral aphthous lesion.
Detailed Description
Prospective study carried out in the Pediatric Dentistry Department of the International University of Catalonia. The sample was made up of children between 3 and 13 years old. Baseline pain status, f...
Eligibility Criteria
Inclusion
- Patients aged 3-13 years.
- Children who presented canker sores.
Exclusion
- Patients who presented canker sores with 48 h of evolution.
- Patients with diabetic disorders.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04677062
Start Date
November 1 2017
End Date
June 30 2019
Last Update
February 1 2021
Active Locations (1)
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1
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain, 08195