Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)

Oral mucositis is one of the most frequent and clinically significant complications inpediatric patients receiving hematopoietic stem cell transplantation (HSCT).Characterized by painful inflammation and ulceration of the oral mucosa, oral mucositiscan substantially impair oral intake, nutritional status, communication, and quality oflife. In severe cases, it may increase the risk of bloodstream infections, require opioidanalgesia, prolong hospitalization, and affect the overall course of transplantation.Currently, preventive and supportive strategies for oral mucositis in HSCT patientsmainly include oral hygiene maintenance, antimicrobial interventions, pain management,and symptomatic treatment. However, the incidence and severity of oral mucositis remainhigh, particularly in pediatric HSCT recipients, due to factors including intensiveconditioning regimens, immature oral care behaviors, altered immune status, and changesin the oral microbiome. Therefore, effective, standardized, and feasible preventive oralcare strategies are still needed.Emerging evidence suggests that maintenance of oral microbial homeostasis and improvementof oral hygiene may play important roles in reducing mucosal injury and preventing theprogression of oral mucositis. However, existing oral care protocols vary considerablyamong institutions, and the effectiveness of comprehensive standardized oral careprograms in pediatric HSCT populations requires further evaluation.This clinical trial aims to evaluate the effectiveness of a standardized oral careintervention program for preventing and reducing oral mucositis in pediatric patientsundergoing HSCT. The intervention integrates structured oral hygiene management, oralcare education, adherence monitoring, and supportive oral management throughout thetransplantation process.The study is designed to provide clinical evidence regarding the role of standardizedoral care in improving oral health outcomes and reducing oral mucositis‐relatedcomplications in pediatric HSCT recipients. The results may contribute to establishingevidence‐based oral care protocols and improving supportive care strategies for childrenundergoing hematopoietic stem cell transplantation.