Brief Title
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
Official Title
Safety, Galenic Acceptability and Efficacy of GV-328 Lozenges in Children With Oral Aphthosis
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 Type
Interventional
Primary Outcome
The level of pain was measured on the Wong-Baker Faces Scale (WBFS)
Secondary Outcome
The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
Condition
Aphthous Stomatitis
Intervention
GV-328
Study Arms / Comparison Groups
GV-328
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
33
Start Date
November 1, 2017
Completion Date
June 30, 2019
Primary Completion Date
June 30, 2019
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.
Gender
All
Ages
3 Years - 13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04677062
Organization ID
UIC-ODP-VIÑAS
Responsible Party
Principal Investigator
Study Sponsor
Universitat Internacional de Catalunya
Study Sponsor
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Verification Date
January 2021