Overview
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.
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.
Eligibility
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
