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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04677062

Enrollment

Registered

2020-12-21

Start date

2017-11-01

Completion date

2019-06-30

Last updated

2021-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous Stomatitis

Keywords

aphthous lesion, hyaluronic acid

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.

Interventions

DRUGGV-328

Patients with GV-328 treatment

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to 13 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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).

Other

Measure	Time frame	Description
The baseline size of the main lesion was also classified according to its diameter	4 DAYS	\<0.5 cm, 0.5-1.0cm or\> 1.0 cm.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026