Recruiting

Dental Cleaning

Sponsor:

Fred Hutchinson Cancer Center

Code:

NCT07535008

Conditions

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dental Cleaning

Dental Plaque sampling

Study Details

Brief summary:

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.

Conditions

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Hematopoietic and Lymphatic System Neoplasm

Study ID

NCT07535008

Start date

Jun 11, 2026

Status verified date

Apr, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prevention (dental cleaning)

Patients undergo simplified dental cleaning on day +28 following HCT.

Interventions

Dental Cleaning

Dental cleaning

Dental Plaque sampling

Ancillary studies

Primary outcome measure

  • Probability of moderate-to-severe chronic graft versus host disease [ Time Frame: At 1-year post-transplant ]

Central Contacts and Locations

Central contacts

Armin Rashidi, MD, PhD

206-667-2506arashidi@fredhutch.org

Locations

Fred Hutch/University of Washington Cancer Consortium

Recruiting

Seattle, Washington, United States, 98109

Contacts

Armin Rashidi, MD, PhD

206-667-2506arashidi@fredhutch.org

Principal Investigator:

Armin Rashidi, MD, PhD

More Information

Sponsor

Fred Hutchinson Cancer Center

Last update posted

Aug 12, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Fred Hutchinson Cancer Center on 2026-08-12.