Hematopoietic stem cell transplantation
Conditions
Interventions
Intervention group:Systematic oral care intervention
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1.Patients aged <=18 years who are scheduled to undergo their first HSCT at our center; 2.Patients with confirmed HSCT indications, including but not limited to acute leukemia, severe aplastic anemia, and thalassemia; 3.Patients are expected to complete baseline oral assessment and intervention within 1 week before HSCT. 4.Stable baseline oral status, defined as WHO grade 0 oral mucositis, with no active oral ulcers, herpetic gingivostomatitis, acute necrotizing ulcerative gingivitis, or untreated odontogenic abscesses. 5.The legal guardians of pediatric patients understand the study procedures and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with severe systemic diseases that may significantly affect short-term survival, including but not limited to NYHA class III–IV heart failure, Child-Pugh class C cirrhosis, and renal failure requiring renal replacement therapy. 2.Patients with uncontrolled systemic active infections prior to HSCT, including but not limited to bloodstream infections and invasive fungal infections. 3.Patients who have received head and neck radiotherapy within 1 month prior to HSCT or have been treated with chemotherapeutic agents known to cause significant oral mucosal toxicity (such as high-dose methotrexate) before HSCT. 4.Patients with underlying conditions that may interfere with oral intervention, including but not limited to uncontrolled severe periodontitis (more than 30% of teeth with probing depth >=5 mm and suppuration), maxillofacial cellulitis or odontogenic abscess requiring urgent surgical management, and diseases severely affecting mouth opening or oral hygiene procedures, such as scleroderma or temporomandibular joint ankylosis. 5.Patients with a known history of hypersensitivity to any components of the oral care products used in the study, including but not limited to chlorhexidine, sodium bicarbonate, or other mouthwash ingredients. 6.Patients who are concurrently participating in other interventional clinical studies that may interfere with the assessment of study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral mucositis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral mucositis pain score;severity of oral mucositis;Changes in salivary IL-6 and IL-1ß levels;Length of hospital stay and medical costs;Duration of oral mucositis; | — |
Countries
China
Contacts
Public ContactChen Ting
Southern Medical University Southern Hospital
Outcome results
None listed