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.

Study Overview

• Status: Recruiting
• Conditions: Acute Graft Versus Host Disease; Chronic Graft Versus Host Disease; Hematopoietic and Lymphatic System Neoplasm
• Intervention / Treatment: Procedure: Dental Cleaning; Procedure: Dental Plaque sampling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armin Rashidi, MD, PhD; Phone Number: 206-667-2506; Email: arashidi@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Armin Rashidi, MD, PhD; Phone Number: 206-667-2506; Email: arashidi@fredhutch.org
      • Principal Investigator: Armin Rashidi, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevention (dental cleaning); Patients undergo simplified dental cleaning on day +28 following HCT.	Procedure: Dental Cleaning; Dental cleaning; Procedure: Dental Plaque sampling; Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Probability of moderate-to-severe chronic graft versus host disease	At 1-year post-transplant

Secondary Outcome Measures

Outcome Measure	Time Frame
Probability of grade III-IV acute graft versus host disease	At 6-months post-transplant
Proportion of eligible patients approached who consent (feasibility)	Up to 2 years
Proportion of enrolled patients who receive the intervention (feasibility)	Up to 2 years

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Armin Rashidi, MD, PhD, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Graft vs Host Disease; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: RG1126351; NCI-2026-02262 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 21222 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No