Oral mucositis is one of the most common and debilitating complications in pediatric patients undergoing hematopoietic stem cell transplantation (HSCT). Severe oral mucositis can lead to pain, nutritional impairment, infection, prolonged hospitalization, and increased healthcare costs. This randomized controlled trial aims to evaluate whether a standardized oral care program consisting of caregiver education, supervised tooth brushing, sodium bicarbonate mouth rinsing, oral moisturizing, and compliance monitoring can reduce the incidence and severity of oral mucositis compared with routine oral care. A total of 126 pediatric HSCT recipients will be randomly assigned in a 1:1 ratio to the intervention or control group. Clinical outcomes, oral pain, inflammatory biomarkers, oral microbiota, and metabolomic profiles will be evaluated throughout the transplantation period.
-Patients aged 1-18 years who undergo hematopoietic stem cell transplantation.
Patients scheduled to receive conditioning therapy before hematopoietic stem cell transplantation.
Patients and/or their legal guardians provide informed consent to participate in the study.
Patients are able to receive oral care intervention and complete oral mucositis assessments during the study period.
Patients with pre-existing oral mucosal diseases or oral ulcers before transplantation.
Patients with severe systemic conditions that may interfere with oral mucositis assessment.
Patients who have received interventions specifically targeting oral mucositis prevention before enrollment.
Patients or guardians who refuse to participate or withdraw informed consent.
Parallel
Standardized Oral Care Intervention
BehavioralThe intervention consists of standardized oral care procedures, including oral hygiene management, oral care education, oral moisturizing, and compliance monitoring throughout the transplantation period.
Routine Oral Care
BehavioralParticipants will receive routine oral care provided according to institutional practice.
Incidence of Oral Mucositis
The incidence of oral mucositis will be assessed according to the World Health Organization (WHO) oral mucositis grading criteria. The proportion of participants who develop oral mucositis of grade ≥1 at any time during the observation period from the day of hematopoietic stem cell transplantation (Day 0) through day 30 after transplantation (Day +30) will be compared between the intervention group and the control group.
Severity of Oral Mucositis
The severity of oral mucositis will be evaluated according to the WHO oral mucositis grading criteria. The maximum mucositis grade and the proportion of participants who develop moderate to severe oral mucositis (grade ≥3) at any time from Day 0 through Day +30 after hematopoietic stem cell transplantation will be recorded and compared between the intervention group and the control group.
Oral Pain Score
Oral pain intensity will be assessed using the Faces Visual Analog Scale (VAS). Pain scores will be assessed during the observation period, and the mean and peak pain scores from Day 0 through Day +30 after hematopoietic stem cell transplantation will be analyzed.
Salivary Inflammatory Cytokine Levels
Unstimulated saliva samples will be collected at five predefined time points during the peri-transplant period. Salivary inflammatory cytokine levels, including interleukin-6 (IL-6) and interleukin-1 beta (IL-1β), will be measured using enzyme-linked immunosorbent assay (ELISA). Changes in cytokine levels across the five time points will be evaluated, and their associations with the incidence and severity of oral mucositis will be explored.
Hospital Stay and Medical Costs
The total length of hospital stay, total hospitalization costs, and the proportion of participants requiring specific treatments related to oral mucositis will be recorded and compared between the intervention group and the control group.
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