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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Patients with GV-328 treatment
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
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
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