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Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)
Sponsor: Nanfang Hospital, Southern Medical University
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.
Official title: Systematic Oral Hygiene Intervention for the Prevention and Control of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation During the Perioperative Period: A Prospective, Randomized Controlled Clinical Trial
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
126
Start Date
2026-09-01
Completion Date
2030-09-01
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
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.
Locations (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China