Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)
Standardized Oral Care InterventionRoutine Oral Care
Standardized Oral Care Intervention: The 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: Participants will receive routine oral care provided according to institutional practice.
Study summary
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.
Eligibility
Sex
ALL
Min age
1 Year
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* -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.
Exclusion Criteria:
* 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.
* Patients who are unable to complete follow-up assessments during the study period.
Primary outcome measure(s)
Incidence of Oral Mucositis — From Day 0 to Day +30 after hematopoietic stem cell transplantation 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.
Trial sites (1)
Facility
City
Region
Status
Nanfang Hospital, Southern Medical University
Guangzhou
Guangdong
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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