Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Aphthous Stomatitis
About this trial
This is an interventional treatment trial for Aphthous Stomatitis focused on measuring aphthous lesion, hyaluronic acid
Eligibility Criteria
Inclusion Criteria:
- Patients aged 3-13 years.
- Children who presented canker sores.
Exclusion Criteria:
- Patients who presented canker sores with 48 h of evolution.
- Patients with diabetic disorders.
Sites / Locations
- Universitat Internacional de Catalunya
Arms of the Study
Arm 1
Experimental
GV-328
The treatment should be carried out for 4 days. Children between 3 and 6 years old had to consume 4 pills a day, children between 7 and 10 years old 5 pills, and children between 11 and 13 years old up to 6 pills. The patient had to slowly thin the tablet in the mouth, maintaining direct contact with the area to be treated. The study consisted of 2 visits, one initial and one final. In the initial visit , the documentation (informed consent) and the treatment were delivered. During this visit, baseline assessments of pain level, functional limitation, marginal mucosal edema, and lesion size were recorded. In addition, a photograph of the area to be treated was taken. Parents were also given a chart, in which they had to record the intensity of pain daily using the Wong-Baker face scale.