Sugar compound in dental wipes may shield kids with leukemia from deadly infections
NCT ID NCT07022678
First seen Jun 24, 2026 · Last updated Sep 04, 2026 · Updated 8 times
Summary
This phase 3 trial tests whether xylitol dental wipes can reduce bloodstream infections in children with acute myeloid leukemia (AML). Xylitol, a natural sugar that limits mouth bacteria growth, is applied via wipes during chemotherapy. The study will compare infection rates between children using xylitol wipes and those using wipes without xylitol, aiming to prevent bacteria from entering the bloodstream through the mouth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- xylitol dental wipes
- What this could lead to
- If it works, this simple, low-cost approach could help prevent dangerous bloodstream infections in children with AML, reducing hospital stays and improving treatment outcomes.
- What could go wrong
- This is a phase 3 trial, but the effect may be modest or not statistically significant. Xylitol wipes are generally safe, but they won't eliminate all infection risks.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 556 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jan 2033
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 25 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Patient must be ≥ 1 year to ≤ 25 years old at enrollment. * Patient must have a diagnosis of AML according to the 2016 World Health Organization classification with or without extramedullary disease. Patients with either newly diagnosed or relapsed AML are eligible as long as they meet the planned treatment criteria. * Patient should be planned to receive at least 2 consecutive cycles of myelosuppressive chemotherapy. Each cycle must: * Contain IV cytarabine (liposomal formulations allowed), and * The duration of severe neutropenia should be expected to be ≥ 7 days. Hematopoietic stem cell transplantation (HSCT) conditioning cannot count as one of the two required planned cycles. Note: Patients do not need to be co-enrolled on an upfront AML treatment protocol study, but co-enrollment is permitted. * Minimum of one visible or erupted tooth. * Agree to avoid xylitol containing gum or toothpaste during intervention period. * All patients and/or their parents or legal guardians must sign a written informed consent. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met. Exclusion Criteria: * Patients with Down syndrome-associated AML. * Prior therapy: Prior radiation treatment for cancer of oral cavity, head or neck in past 6 months per study participant's medical record. * Patients with known history of allergy to xylitol. * Patients with known history of allergy to grapes or grape flavoring. * Patients who are actively being treated for an oral organism related blood stream infection. * Patients for whom the practitioner believes are unable to comply with use of oral dental wipes.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
39 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
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Locations
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Albany Medical Center
RECRUITINGAlbany, New York, 12208, United States
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Alfred I duPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
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Arkansas Children's Hospital
RECRUITINGLittle Rock, Arkansas, 72202-3591, United States
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Blank Children's Hospital
RECRUITINGDes Moines, Iowa, 50309, United States
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Bronson Methodist Hospital
RECRUITINGKalamazoo, Michigan, 49007, United States
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C S Mott Children's Hospital
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Hospital of Alabama
RECRUITINGBirmingham, Alabama, 35233, United States
Contact Email: •••••@•••••
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Children's Hospital of Pittsburgh of UPMC
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of The King's Daughters
RECRUITINGNorfolk, Virginia, 23507, United States
Contact Email: •••••@•••••
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Dell Children's Medical Center of Central Texas
RECRUITINGAustin, Texas, 78723, United States
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Driscoll Children's Hospital
RECRUITINGCorpus Christi, Texas, 78411, United States
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East Tennessee Childrens Hospital
RECRUITINGKnoxville, Tennessee, 37916, United States
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Geisinger Medical Center
RECRUITINGDanville, Pennsylvania, 17822, United States
Contact Email: •••••@•••••
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Golisano Children's Hospital of Southwest Florida
RECRUITINGFort Myers, Florida, 33908, United States
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Kaiser Permanente-Oakland
RECRUITINGOakland, California, 94611, United States
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Lurie Children's Hospital-Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Maine Children's Cancer Program
RECRUITINGScarborough, Maine, 04074, United States
Contact Email: •••••@•••••
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Medical City Dallas Hospital
RECRUITINGDallas, Texas, 75230, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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Nemours Children's Clinic - Pensacola
RECRUITINGPensacola, Florida, 32504, United States
Contact Email: •••••@•••••
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Nemours Children's Clinic-Jacksonville
RECRUITINGJacksonville, Florida, 32207, United States
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Nemours Children's Hospital
RECRUITINGOrlando, Florida, 32827, United States
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Norton Children's Hospital
RECRUITINGLouisville, Kentucky, 40202, United States
Contact Email: •••••@•••••
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Presbyterian Hospital
RECRUITINGAlbuquerque, New Mexico, 87106, United States
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ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
RECRUITINGToledo, Ohio, 43606, United States
Contact Email: •••••@•••••
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Providence Sacred Heart Medical Center and Children's Hospital
RECRUITINGSpokane, Washington, 99204, United States
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Rainbow Babies and Childrens Hospital
RECRUITINGCleveland, Ohio, 44106, United States
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Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
RECRUITINGDenver, Colorado, 80218, United States
Contact Email: •••••@•••••
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Saint Vincent Hospital Cancer Center Green Bay
RECRUITINGGreen Bay, Wisconsin, 54301, United States
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Sanford Broadway Medical Center
RECRUITINGFargo, North Dakota, 58122, United States
Contact Email: •••••@•••••
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The Children's Hospital at TriStar Centennial
RECRUITINGNashville, Tennessee, 37203, United States
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UT Southwestern/Simmons Cancer Center-Dallas
RECRUITINGDallas, Texas, 75390, United States
Contact Email: •••••@•••••
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University of Kentucky/Markey Cancer Center
NOT_YET_RECRUITINGLexington, Kentucky, 40536, United States
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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Valley Children's Hospital
RECRUITINGMadera, California, 93636, United States
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Department of hematology, the second affiliated hospital of kunming medical university.
- The prognostic significance of C-Reactive protein to albumin ratio, albumin to fibrinogen ratio, and serum ferritin level in newly diagnosed de novo Non-M3 acute myeloid leukemia patients
- Impact of aloe vera mouthwash on the prevention and severity of oral mucositis in adults in with hematologic malignancies
- Can a new drug pair beat standard chemotherapy for tough AML?
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- Can a targeted drug combo replace harsh chemo for NPM1 leukemia?