Recurrent aphthous stomatitis Oral Health Mouth ulcers
Conditions
Interventions
70 patients with the complaint of RAS will be enrolled in this study, and will be randomly be assigned to the Test or the Placebo group in an equal ratio (1:1, 35 subjects in each group). The Test gro
Sponsors
University of Milan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged between 12 and 50 years 2. Presence of at least one aphthous ulcer in an easily accessible area of the mouth and reporting pain
Exclusion criteria
Exclusion criteria: 1. Pregnancy and lactation 2. Systemic disease such as Crohn’s disease, Behçet’s syndrome or ulcerative colitis 3. HIV, hepatitis C, or other systemic, acute or chronic infections 4. Use of other medications or drugs within 2 months, and specifically use of any local treatment for ulcers within 48 h of the start of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using a visual analogue scale (VAS) at baseline, then before, right after, 20 and 60 min after drug application, three times daily, for seven days (a total of 84 measurements for each patient) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ulcer size is measured using a periodontal probe, two measurements of the distance between the two opposite outer edges of the white margin of the ulcer perpendicular to each other passing through the center of the lesion will be obtained and then multiplied to calculate the cross-sectional area of the ulcer, at baseline, then every 24 h for 7 days | — |
Countries
Italy
Contacts
Public ContactMaggie Stephen F. Fahim
Outcome results
None listed