An interventional study of GV-328 in Aphthous Stomatitis, sponsored by Universitat Internacional de Catalunya. Completed at 1 site in Spain. Open to participants aged 3 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Universitat Internacional de Catalunya · Not applicable, Interventional, and Treatment
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.
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.
63 studies on the registry are indexed under Stomatitis, Aphthous; 17 are open to participants now.
This study's enrollment of 33 is below the median of 41 across 54 interventional studies indexed under Stomatitis, Aphthous.
Browse Stomatitis, Aphthous studies →Universitat Internacional de Catalunya is the lead sponsor of 151 studies on the registry; 46 are open to participants now.
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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.
Drug: GV-328
Patients with GV-328 treatment
The level of pain was measured on the Wong-Baker Faces Scale (WBFS)
It consists of a 6-point scale that ranges from 0 (no pain) to 5 (excruciating pain).
Time frame: 4 DAYS
The degree of functional limitation and edema in the marginal mucosa were measured using a Likert scale.
(0-absent, 1-mild, 2-moderate, 3-intense, 4-very intense).
Time frame: 4 DAYS
The baseline size of the main lesion was also classified according to its diameter
\<0.5 cm, 0.5-1.0cm or\> 1.0 cm.
Time frame: 4 DAYS
Ran from Nov 2017 to primary completion in Jun 2019, 19 months.
Of 13 interventional studies with no phase under Stomatitis, Aphthous, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 19. This study's 19 months is above that.
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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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