The purpose of this study is to evaluate the efficacy and safety of BNP105 in the treatment of recurrent aphthous stomatitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
102
BNP105 oral suspension, 25 mg + 25 mg + 15 mg, oral. Up to six applications per day.
Placebo. Up to six applications per day.
EMS
Hortolândia, São Paulo, Brazil
NOT_YET_RECRUITINGCecip Jau - Centro de Estudos Clinicos Do Interior Paulista Ltda
Jaú, São Paulo, Brazil
RECRUITINGTo assess the change in pain intensity after the first application.
Difference in pain intensity 3 and 10 minutes after the first application of the medication compared to baseline, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
Time frame: 3 and 10 minutes
To assess the change in pain intensity after 3 days of treatment.
Difference in pain intensity after 3 days of treatment compared to baseline. Pain intensity will be evaluated by the Visual Analogue Scale (VAS). The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
Time frame: 3 days
To assess the pain intensity daily after breakfast, lunch and dinner.
Pain intensity will be evaluated daily after breakfast, lunch and dinner by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
Time frame: 7 days
To assess the pain intensity daily at night.
Pain intensity will be evaluated daily at night by the Numeric Pain Rating Scale (NPRS). The NPRS is an 11-point scale scored from 0-10 representing 0 ("no pain") and 10 (Worst Possible Pain").
Time frame: 7 days
To assess the oral health-related quality of life
The oral health-related quality of life will be evaluated daily at night by the adapted Oral Health Impact Profile (OHIP) questionary.
Time frame: 7 days
Percentage of participants healed after 3 days of treatment.
Percentage of participants healed after 3 days of treatment, defined as ulcer diameter = 0 mm and pain intensity = 0, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
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Time frame: 3 days
Percentage of participants with no pain after 3 days of treatment.
Percentage of participants with no pain after 3 days of treatment, defined as pain intensity = 0, measured by the VAS scale. The VAS consists of a 100 mm line, with two end points representing 0 ("no pain") and 100 (Worst Possible Pain").
Time frame: 3 days
Global assessment of treatment by participant after 3 days of treatment
The global evaluation of the treatment after 3 days of treatment will be evaluated by the categorical scale of 5 points representing 0 = very bad, 1 = bad, 2 = indifferent, 3 = good and 4 = very good.
Time frame: 3 days