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

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 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

, , 

Location Countries

Spain

Location Countries

Spain

NCT ID

NCT04677062

Organization ID

UIC-ODP-VIÑAS

Responsible Party

Principal Investigator

Study Sponsor

Universitat Internacional de Catalunya

Study Sponsor

, , 

Verification Date

January 2021