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Can toothbrushing and rinses stop painful mouth sores in child transplant patients?

NCT ID NCT07809451

Prevention Sponsor: Nanfang Hospital, Southern Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Children who receive hematopoietic stem cell transplants often develop painful mouth sores called oral mucositis, which can lead to poor eating, infection, and longer hospital stays. This trial tests whether a structured oral care program, including caregiver education, supervised tooth brushing, baking soda rinses, and mouth moisturizing, can prevent or reduce these sores compared with usual care. Researchers will randomly assign 126 children aged 1 to 18 to either the structured program or routine oral care and track mouth sore incidence, severity, pain, and biological markers for 30 days after transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a standardized oral care program with caregiver education, supervised tooth brushing, baking soda rinses, and mouth moisturizing
What this could lead to
If it works, this could give transplant centers a simple, low-cost way to prevent painful mouth sores in children receiving stem cell transplants.
What could go wrong
Mouth sores after transplant have many causes, so better brushing and rinsing may not be enough to prevent them. The trial is small and single-center, so results may not apply everywhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * -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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

stomatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematopoietic stem cell transplantation (HSCT) Oral mucositis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

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