NCT07809451

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
48mo left

Started Sep 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Sep 2030

First Submitted

Initial submission to the registry

August 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2029

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2030

Last Updated

September 9, 2026

Status Verified

September 1, 2026

Enrollment Period

3 years

First QC Date

August 30, 2026

Last Update Submit

September 2, 2026

Conditions

Oral MucositisHematopoietic Stem Cell Transplantation (HSCT)

Keywords

Oral mucositisHematopoietic stem cell transplantationPediatric patientsOral careSupportive care

Outcome Measures

Primary Outcomes (1)

  • 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.

    From Day 0 to Day +30 after hematopoietic stem cell transplantation

Secondary Outcomes (1)

  • Severity of Oral Mucositis

    From Day 0 to Day +30 after hematopoietic stem cell transplantation

Other Outcomes (3)

  • Oral Pain Score

    From Day 0 to Day +30 after hematopoietic stem cell transplantation

  • Salivary Inflammatory Cytokine Levels

    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

    From Day 0 after hematopoietic stem cell transplantation to hospital discharge

Study Arms (2)

Standardized Oral Care Intervention Group

EXPERIMENTAL

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

Routine Oral Care Group

ACTIVE COMPARATOR

Participants will receive routine oral care according to the current institutional practice during the hematopoietic stem cell transplantation period.

Behavioral: Routine Oral Care

Interventions

Routine Oral CareBEHAVIORAL

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

Routine Oral Care Group
Standardized Oral Care InterventionBEHAVIORAL

The intervention consists of standardized oral care procedures, including oral hygiene management, oral care education, oral moisturizing, and compliance monitoring throughout the transplantation period.

Standardized Oral Care Intervention Group

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (6)

  • Raber-Durlacher JE, Zadik Y, Treister NS, Stempler N, Bruno JS, Epstein JB, Elad S. MASCC/ISOO clinical practice statement: Current understanding on controversies in basic oral care in hemato-oncology and hematopoietic cell transplantation. Support Care Cancer. 2024 Jul 25;32(8):550. doi: 10.1007/s00520-024-08690-1.

    PMID: 39048882BACKGROUND

  • Potting CMJ, van Leeuwen SJM, Kurstjens MH, Bronkhorst EM, Thomas RZ, Blijlevens NMA, Huysmans MDNJM. A randomized controlled trial of manual versus powered tooth brushing during haematopoietic stem cell transplantation. Oral Dis. 2022 Oct;28(7):1987-1994. doi: 10.1111/odi.13899. Epub 2021 May 20.

    PMID: 33964053BACKGROUND

  • de Lima Martins JO, Carlos ACAM, Costa GAJ, Ribeiro RS, Malta CEN, Borges MMF, de Moura JFB, de Arruda LM, Costa FWG, de Barros Silva PG. Oral hygiene protocols reduce the severity and incidence of oral mucositis during antineoplastic treatment: a systematic review and meta-analysis of randomized and non-randomized clinical trials. Support Care Cancer. 2023 Jul 21;31(8):480. doi: 10.1007/s00520-023-07858-5.

    PMID: 37477721BACKGROUND

  • Agholme MB, Dahllof G, Torlen JK, Majorana A, Brennan MT, von Bultzingslowen I, Tan PL, Hu S, Sim YF, Hong C. Incidence, severity, and temporal development of oral complications in pediatric allogeneic hematopoietic stem cell transplant patients - a multicenter study. Support Care Cancer. 2023 Nov 16;31(12):702. doi: 10.1007/s00520-023-08151-1.

    PMID: 37971651BACKGROUND

  • Alhussain A, Alkhayal Z, Ayas M, Abed H. Prevalence and risk factors of oral mucositis in paediatric patients undergoing haematopoietic stem cell transplantation. Oral Dis. 2022 Apr;28(3):657-669. doi: 10.1111/odi.13777. Epub 2021 Feb 2.

    PMID: 33453145BACKGROUND

  • Patel P, Robinson PD, Baggott C, Gibson P, Ljungman G, Massey N, Ottaviani G, Phillips R, Revon-Riviere G, Treister N, White M, Cabral S, Dupuis L, Sung L. Clinical practice guideline for the prevention of oral and oropharyngeal mucositis in pediatric cancer and hematopoietic stem cell transplant patients: 2021 update. Eur J Cancer. 2021 Sep;154:92-101. doi: 10.1016/j.ejca.2021.05.013. Epub 2021 Jul 9.

    PMID: 34252760BACKGROUND

MeSH Terms

Conditions

Stomatitis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Ting Chen, PhD

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhuoting Yuan

CONTACT

+86-1827966733418279667334@163.com

Yan Lin

CONTACT

+86-19128424850linyandent@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the oral care intervention, masking of participants and care providers is not feasible.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This is a randomized, controlled, parallel-group clinical trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either a standardized oral care intervention or routine oral care. Randomization will be performed using a computer-generated block randomization method with allocation concealment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2026

First Posted

September 9, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

September 1, 2029

Study Completion (Estimated)

September 1, 2030

Last Updated

September 9, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

CN(1)