Dental Cleaning to Prevent Chronic Graft-Versus-Host Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dental Cleaning, Dental Plaque sampling.
- Who it may be relevant to
- Registry conditions: Chronic Graft Versus Host Disease, Acute Graft Versus Host Disease, Hematopoietic and Lymphatic System Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
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.
Interventions
- Procedure Dental Cleaning
Dental cleaning - Procedure Dental Plaque sampling
Ancillary studies
Primary outcome measures
- Probability of moderate-to-severe chronic graft versus host disease [Time frame: At 1-year post-transplant]
Secondary outcome measures (3)
- Probability of grade III-IV acute graft versus host disease [Time frame: At 6-months post-transplant]
- Proportion of eligible patients approached who consent (feasibility) [Time frame: Up to 2 years]
- Proportion of enrolled patients who receive the intervention (feasibility) [Time frame: Up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Fred Hutch/University of Washington Cancer Consortium — Seattle
Identifiers
NCT: NCT07535008 · RG1126351 · NCI-2026-02262 · 21222