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

Not Applicable

Completed

• Conditions: Aphthous Stomatitis
• Interventions: Drug: GV-328

• Registration Number: NCT04677062
• Lead Sponsor: Universitat Internacional de Catalunya

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, 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.

Study Timeline

• Study Start: 2017-11-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Patients aged 3-13 years.
• Children who presented canker sores.

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Exclusion Criteria

• Patients who presented canker sores with 48 h of evolution.
• Patients with diabetic disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GV-328	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain