Oral Mucosal Diseases
Conditions
Interventions
Experimental Group:After diluting dexamethasone sodium phosphate injection 1:10, dip it in a cotton swab and apply it to the ulcer lesion, and then use an oral patch to cover the lesion 3 times a day
Control Group:Dexamethasone sodium phosphate injection was diluted 1:10 and then dipped in a cotton swab and applied to the lesion area, 3 times a day, used for 5 consecutive days or until the lesion
Sponsors
West China Hospital of Stomatology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: a. Age 18 to 65 years old, gender is not limited; b. Patients who meet the diagnostic criteria for recurrent aphthous ulcer and are clinically classified as mild; c. The ulcer occurred within 48 hours and without any treatment; d. Within 24 hours before enrollment, the VAS score of ulcer irritation pain was >=4 points, 3mm<=target ulcer length and diameter<=10mm, and the number of ulcers was 1~5; e. Those who agree to participate in this clinical trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: a. Known or suspected history of allergy or serious adverse reactions to the test drug and its excipients; b. Severe aphthous ulcer, herpetiform aphthous ulcer, acute herpetic gingivostomatitis, traumatic ulcer, cancerous ulcer, tuberculous ulcer, syphilitic ulcer, necrotizing salivary gland metaplasia, Behcet's disease and ulcers caused by other diseases or drugs, etc.; c. Have taken immunosuppressants or corticosteroids within two weeks before enrollment, and used painkillers, anti-allergy drugs and other drugs that may affect the efficacy of pain observation within 24 hours before enrollment; d. Patients with upper respiratory tract infection; e. Patients with other painful oral lesions that may affect the observation of efficacy, such as: patients with pericoronitis, acute pulpitis, acute apical inflammation and other diseases; f. Those who are unable to cooperate or unwilling to cooperate due to neurological or psychiatric disorders; g. Patients with severe systemic diseases; h. Pregnant and lactating women; i. Other conditions that are considered inappropriate by the investigator to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retention Time;Therapeutic Efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Security; | — |
Countries
China
Contacts
Public ContactJiongke Wang
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed