Recurrent aphthous ulcer
Conditions
Interventions
Trial group:Conventional drug therapy + Bactoblis Active Probiotic Complex Tablets (Compressed Candy)
Control group:Conventional drug therapy + Bactoblis Active Probiotic Complex Tablets (Compressed Candy) placebo
Sponsors
Stomatological Hospital of Shandong University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of RAU based on patient history (periodic recurrence, self-limiting nature) and typical ulcer presentation (red halo, yellow pseudomembrane, central depression, and pain). 2. Aged 18–60 years. 3. RAU history >= 6 months, with a total of >= 3 documented episodes. 4. Diagnosis of minor RAU, with 1–3 ulcers in the current episode and ulcer diameter ranging from 2–9 mm. 5. Current ulcer onset <= 48 hours and no prior medication intervention for this episode. 6. Ulcer site(s) accessible for clinical examination. 7. Simplified Oral Hygiene Index (OHI-S) score of 0, including both the Simplified Debris Index (DI-S) and the Simplified Calculus Index (CI-S).
Exclusion criteria
Exclusion criteria: 1. Diagnosis of major RAU, herpetiform RAU, Behçet’s disease, or other severe oral mucosal diseases (e.g., oral lichen planus, bullous disorders, oral candidiasis, etc.). 2. Presence of severe systemic, infectious, or autoimmune diseases. 3. Use of corticosteroids, immunosuppressants, antibiotics, or probiotics within the past month, or use of topical ulcer-related medications within the past week. 4. History of allergies, known hypersensitivity to any ingredient of the test product, or inability to accept strawberry flavor. 5. Clinically significant abnormalities in laboratory tests. 6. Pregnancy, lactation, or women of childbearing age planning pregnancy. 7. Heavy smoking or alcohol use. 8. Participation in other clinical trials within the past 90 days, or use of probiotic toothpaste/mouthwash. 9. Inability to comply with medical instructions or attend follow-up visits as scheduled. 10. Any other condition deemed inappropriate for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ulcer-free days; | — |
Secondary
| Measure | Time frame |
|---|---|
| Recurrence interval (days);Numeric rating scale (NRS);Number of ulcers;Ulcerf size;Days for ulcer healing; | — |
Countries
China
Contacts
Public ContactWang Wenxia
School and Hospital of Stomatology, Shandong University
Outcome results
None listed