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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Incidence of Oral Mucositis
研究概览
简要总结
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.
详细描述
Oral mucositis is one of the most frequent and clinically significant complications in pediatric patients receiving hematopoietic stem cell transplantation (HSCT). Characterized by painful inflammation and ulceration of the oral mucosa, oral mucositis can substantially impair oral intake, nutritional status, communication, and quality of life. In severe cases, it may increase the risk of bloodstream infections, require opioid analgesia, prolong hospitalization, and affect the overall course of transplantation.
Currently, preventive and supportive strategies for oral mucositis in HSCT patients mainly include oral hygiene maintenance, antimicrobial interventions, pain management, and symptomatic treatment. However, the incidence and severity of oral mucositis remain high, particularly in pediatric HSCT recipients, due to factors including intensive conditioning regimens, immature oral care behaviors, altered immune status, and changes in the oral microbiome. Therefore, effective, standardized, and feasible preventive oral care strategies are still needed.
Emerging evidence suggests that maintenance of oral microbial homeostasis and improvement of oral hygiene may play important roles in reducing mucosal injury and preventing the progression of oral mucositis. However, existing oral care protocols vary considerably among institutions, and the effectiveness of comprehensive standardized oral care programs in pediatric HSCT populations requires further evaluation.
This clinical trial aims to evaluate the effectiveness of a standardized oral care intervention program for preventing and reducing oral mucositis in pediatric patients undergoing HSCT. The intervention integrates structured oral hygiene management, oral care education, adherence monitoring, and supportive oral management throughout the transplantation process.
The study is designed to provide clinical evidence regarding the role of standardized oral care in improving oral health outcomes and reducing oral mucositis-related complications in pediatric HSCT recipients. The results may contribute to establishing evidence-based oral care protocols and improving supportive care strategies for children undergoing hematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Due to the nature of the oral care intervention, masking of participants and care providers is not feasible.
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-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.
排除标准
- •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.
研究组 & 干预措施
Standardized Oral Care Intervention Group
Participants will receive a standardized oral care intervention during the hematopoietic stem cell transplantation period, including structured oral hygiene management, oral care education, and adherence monitoring.
干预措施: Standardized Oral Care Intervention (Behavioral)
Routine Oral Care Group
Participants will receive routine oral care according to the current institutional practice during the hematopoietic stem cell transplantation period.
干预措施: Routine Oral Care (Behavioral)
结局指标
主要结局
Incidence of Oral Mucositis
时间窗: 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.
次要结局
- Severity of Oral Mucositis(From Day 0 to Day +30 after hematopoietic stem cell transplantation)