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NOT YET RECRUITING
NCT07809451
NA

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

View on ClinicalTrials.gov

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

BEHAVIORAL

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.

BEHAVIORAL

Routine Oral Care

Participants will receive routine oral care provided according to institutional practice.

Locations (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China