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NCT Number: NCT07535008

Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease

This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease (GVHD) in patients undergoing an allogeneic hematopoietic cell transplant (HCT). HCT is the only curative treatment for some types of blood cancer. Unfortunately, this approach can lead to the development of GVHD, which is a disease caused when cells from a donated stem cell graft attack the normal tissue of the transplant patient. Some research has shown that the bacteria that is present in the dental plaque soon after transplant may affect the development of chronic GVHD. Dental cleanings prior to transplant are part of the normal standard of care for patients undergoing HCT. Adding an additional cleaning shortly after HCT may be effective for preventing the development of chronic GVHD.

Recruiting

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Key information

Conditions

Chronic Graft Versus Host Disease Acute Graft Versus Host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Hematopoietic and Lymphatic System Neoplasm Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

Armin Rashidi, MD, PhD

CONTACT

[email protected]

206-667-2506

Armin Rashidi, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

OUTLINE:

Patients who have not undergone dental cleaning within 3 months preceding the baseline visit undergo dental cleaning at baseline (before the initiation of transplant conditioning) according to standard of care. All patients undergo simplified dental cleaning on day +28 following HCT.

After completion of study intervention, patients are followed up on days +84 and +180 and at 1 year.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years old
  • T-replete allogeneic hematopoietic cell transplantation for any indication. History of prior transplantation is allowed. Any conditioning regimen is allowed
  • One of the following HCT donor types:
  • 9/10 or 10/10 human leukocyte antigen (HLA)-matched unrelated donor
  • Cord blood
  • Willing to have an in-person 1-year long-term follow-up (LTFU) visit including an oral medicine at Fred Hutch (FH)
  • Ability to understand and sign a written informed consent document (or legal representative)

Exclusion criteria

  • Edentulous state
  • Bone marrow as graft source
  • Use of post-transplantation cyclophosphamide (PTCy) or ruxolitinib as GVHD prophylaxis
  • Use of anti-thymocyte globulin (ATG) in conditioning

Treatment and study plan

Dental Cleaning

Procedure

Dental cleaning

Dental Plaque sampling

Procedure

Ancillary studies

Primary outcomes

  1. Probability of moderate-to-severe chronic graft versus host disease

    Time frame: At 1-year post-transplant

Secondary outcomes

  1. Probability of grade III-IV acute graft versus host disease

    Time frame: At 6-months post-transplant

  2. Proportion of eligible patients approached who consent (feasibility)

    Time frame: Up to 2 years

  3. Proportion of enrolled patients who receive the intervention (feasibility)

    Time frame: Up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Armin Rashidi, MD, PhD

CONTACT

[email protected]

206-667-2506

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 16, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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