An interventional study of Standardized Oral Care Intervention and Routine Oral Care in Oral Mucositis and Hematopoietic Stem Cell Transplantation (HSCT), sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 1 site in China. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Prevention
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.
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.
306 studies on the registry are indexed under Stomatitis; 75 are open to participants now.
This study's planned enrollment of 126 is above the median of 60 across 276 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Nanfang Hospital, Southern Medical University is the lead sponsor of 490 studies on the registry; 214 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Standardized Oral Care Intervention
Participants will receive routine oral care according to the current institutional practice during the hematopoietic stem cell transplantation period.
Behavioral: Routine Oral Care
The intervention consists of standardized oral care procedures, including oral hygiene management, oral care education, oral moisturizing, and compliance monitoring throughout the transplantation period.
Participants will receive routine oral care provided according to institutional practice.
Incidence of Oral Mucositis
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.
Time frame: From Day 0 to Day +30 after hematopoietic stem cell transplantation
Severity of Oral Mucositis
The severity of oral mucositis will be evaluated according to the WHO oral mucositis grading criteria. The maximum mucositis grade and the proportion of participants who develop moderate to severe oral mucositis (grade ≥3) at any time from Day 0 through Day +30 after hematopoietic stem cell transplantation will be recorded and compared between the intervention group and the control group.
Time frame: From Day 0 to Day +30 after hematopoietic stem cell transplantation
Oral Pain Score
Oral pain intensity will be assessed using the Faces Visual Analog Scale (VAS). Pain scores will be assessed during the observation period, and the mean and peak pain scores from Day 0 through Day +30 after hematopoietic stem cell transplantation will be analyzed.
Time frame: From Day 0 to Day +30 after hematopoietic stem cell transplantation
Salivary Inflammatory Cytokine Levels
Unstimulated saliva samples will be collected at five predefined time points during the peri-transplant period. Salivary inflammatory cytokine levels, including interleukin-6 (IL-6) and interleukin-1 beta (IL-1β), will be measured using enzyme-linked immunosorbent assay (ELISA). Changes in cytokine levels across the five time points will be evaluated, and their associations with the incidence and severity of oral mucositis will be explored.
Time frame: Baseline (T0), Day 0 (T1), Day +7 (T2), Day +14 (T3), and Day +30 (T4) after hematopoietic stem cell transplantation
Hospital Stay and Medical Costs
The total length of hospital stay, total hospitalization costs, and the proportion of participants requiring specific treatments related to oral mucositis will be recorded and compared between the intervention group and the control group.
Time frame: From Day 0 after hematopoietic stem cell transplantation to hospital discharge
Plan to share: No — Individual participant data will not be shared because this study involves pediatric hematopoietic stem cell transplantation recipients and includes sensitive clinical information and biological sample-related data. To protect participant privacy and confidentiality, data will be managed and stored according to ethical approval requirements and institutional policies.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 65 non-industry interventional studies with no phase under Stomatitis, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 36 months is above that.
Counting every sponsor, half of 73 studies reached it within 14 months; a quarter within 10 and three quarters within 32.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Nanfang Hospital, Southern Medical University →