Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

Study Overview
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Brief Summary
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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
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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, functional limitation, edema and lesion diameter were evaluated. The treatment lasted 4 days. The parents recorded the intensity of the pain and the number of pills provided daily. Statistical significance was accepted with p≤0.05 and a 95% confidence interval. A total sample of 33 patients, 11 boys (33 %) and 22 girls (67 %) was obtained. The average age of the children was 7.8 years (SD: 1.41). Numerical variables referring to pain, inflammation and edema presented statistically significant improvements (p-value <0.05). Healing efficacy was demonstrated in 13 cases (39 %) and only 3 cases (9 %) reported poor taste acceptability.

Official Title
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Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis

Conditions
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Aphthous Stomatitis

Intervention / Treatment
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* Drug: GV-328


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GV-328<br>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. | Drug: GV-328<br>* Patients with GV-328 treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of pain was measured on the Wong-Baker Faces Scale (WBFS) | It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain). | 4 DAYS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale. | (0-absent, 1-mild, 2-moderate, 3-intense, 4-very intense). | 4 DAYS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aphthous lesion, hyaluronic acid