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Completed

NCT Number: NCT04677062

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

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.

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Key information

Conditions

Aphthous Stomatitis Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GV-328

Drug

Patients with GV-328 treatment

Primary outcomes

  1. The level of pain was measured on the Wong-Baker Faces Scale (WBFS)

    Time frame: 4 DAYS

    It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain).

Secondary outcomes

  1. The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.

    Time frame: 4 DAYS

    (0-absent, 1-mild, 2-moderate, 3-intense, 4-very intense).

Other outcomes

  1. The baseline size of the main lesion was also classified according to its diameter

    Time frame: 4 DAYS

    <0.5 cm, 0.5-1.0cm or> 1.0 cm.

Sponsors and collaborators

Lead sponsor

Universitat Internacional de Catalunya

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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