Recurrent aphthous stomatitis
Conditions
Interventions
Test group:mucoadhesive oral film containing chitosan
Control group:mucoadhesive oral film with no active ingredients
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 60 years; (2) Volunteered to participate in this study and could precisely follow the study protocol; (3) Willing to sign the informed consent form and offer the medical history; (4) A history of RAS for a minimum of 6 months with an average healing time of at least 5 days; (5) Fresh ulcers available within less than 48 hours from eruption; (6) No drugs had been used to treat the fresh ulcers and participants were not in any other clinical trials.
Exclusion criteria
Exclusion criteria: (1) Herpetiform ulcers or major aphthous ulcer; (2) Ulcers associated with systemic diseases, such as Behcets disease or Crohns disease; (3) Patients suffering from severe diseases including but not limited to arrhythmia, uncontrolled hypertension, diabetes, hepatitis and renal failure; (4) Pregnant or lactating women, as well as those who were preparing for pregnancy during the study; (5) Poor health that cannot be fasted for 2 hours; (6) Poor oral hygiene requiring treatment; (7) Allergic to shrimp, crab, shellfish and sesame oil; (8) Received analgesics within 24 hours, antibiotics within 1 month and glucocorticoids and immunosuppressors within 3 months; (9) Patients suffering from chronic diseases, that required treatment with antibiotics, hormones, non-steroidal anti-inflammatory drugs, immunosuppressants, immunoenhancers, cytotoxic drugs or cell cycle agents which have effects on the oral mucosa; (10) Patients with mental diseases or limited in mental capacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ulcer size;ulcer pain score; | — |
Countries
China
Contacts
Public ContactHaiwen Zhou
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed