Dental Cleaning for GVHD
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a dental cleaning soon after a stem cell transplant can help prevent chronic graft versus host disease (GVHD), a condition where donor cells attack the patient's body. Research has shown that bacteria in dental plaque may influence the development of GVHD. The trial will include a simplified dental cleaning about a month after the transplant to assess its impact. Individuals who have undergone an allogeneic hematopoietic cell transplant (a stem cell transplant using donor cells) and meet specific donor criteria may be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to understanding how dental care might improve outcomes for transplant patients.
Do I need to stop my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are using cyclophosphamide or ruxolitinib for GVHD prevention, you cannot participate in the trial.
What prior data suggests that this dental cleaning is safe for preventing chronic GVHD?
Research has shown that dental cleanings are generally safe and well-tolerated. This study explores whether a dental cleaning after a stem cell transplant can help prevent chronic graft versus host disease (GVHD), a condition where transplanted cells attack the body. Dental cleaning is already a standard step before transplants, and an additional cleaning soon after might help prevent GVHD.
Dental cleanings, which involve removing plaque and tartar from teeth, are routine procedures with minimal risk of side effects. Previous studies have found that regular dental care can reduce mouth problems in patients with GVHD. Therefore, an extra cleaning might lower the risk of developing oral issues related to GVHD, suggesting that participants are likely to tolerate the treatment well.12345Why are researchers excited about this trial?
Unlike the standard options for managing graft-versus-host disease (GVHD), which typically involve medications to suppress the immune system, this treatment focuses on a simple, non-invasive method: dental cleaning. Researchers are excited about this approach because it targets oral health, which is often overlooked in GVHD management, potentially preventing complications without the side effects of drugs. This technique could offer an easy, cost-effective way to improve quality of life for patients after hematopoietic cell transplantation (HCT).
What evidence suggests that dental cleaning might be an effective treatment for preventing chronic GVHD?
Studies have shown that bacteria in dental plaque after a stem cell transplant can influence the development of chronic graft versus host disease (GVHD). Research indicates that many patients who neglected oral care before their transplant developed mouth problems related to GVHD. In this trial, participants will receive dental cleanings as a preventive measure on day +28 following their transplant. Dental cleanings, already part of routine pre-transplant care, might reduce these risks if performed soon after the transplant as well. By maintaining oral hygiene, the growth of harmful bacteria may be minimized, potentially preventing chronic GVHD. While more evidence is needed to confirm its effectiveness, the link between oral health and GVHD development is clear.56789
Who Is on the Research Team?
Armin Rashidi, MD, PhD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
This trial is for adults (18+) who have received a T-cell replete allogeneic stem cell transplant for any reason, can attend follow-up visits at Fred Hutch, and have certain donor types. People without teeth or those treated with specific drugs or bone marrow grafts can't join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Dental Cleaning
Patients undergo dental cleaning at baseline before the initiation of transplant conditioning according to standard of care
Post-transplant Dental Cleaning
Patients undergo simplified dental cleaning on day +28 following HCT
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dental Cleaning
Trial Overview
The study tests if an extra dental cleaning soon after a stem cell transplant helps prevent chronic GVHD compared to standard care. Dental plaque samples are also collected to study bacteria in the mouth.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo simplified dental cleaning on day +28 following HCT.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fred Hutchinson Cancer Center
Lead Sponsor
Citations
A Review of Oral Chronic Graft-Versus-Host Disease - PMC
The purpose of this review is to provide an overview of alloHCT and its oral health considerations, with a focus on oral cGVHD etiology, signs and symptoms, and ...
Oral Chronic Graft-versus-Host Disease and Oral Health ...
This review provides a practical and concise approach to the diagnosis and management of oral health needs in pediatric and adult alloHCT recipients
Oral Chronic Graft-Versus-Host Disease
The aim of this mini-review is to provide an up-to-date review of literature related to the diagnosis and management of oral cGVHD to aid dental ...
Oral Manifestations of Graft vs. Host Disease
This pictorial review provides a background of GVHD to dental practitioners, describes the most common oral manifestations of GVHD, and highlights the main ...
Identification of oral risk factors for chronic graft versus host ...
Overall, 64% of patients (N=30) did not perform dental hygiene during the screening pre-transplant and 53% (25/47) developed cGvHD with oral involvement. The ...
Oral Graft-Versus-Host Disease: A Pictorial Review and ... - PMC
It may indirectly affect the teeth and the oral flora, putting the patient at risk for infections. Importantly, GVHD poses an increased risk for oral cancer.
Dental Cleaning to Prevent Chronic Graft-Versus-Host ...
There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...
Oral Chronic Graft-versus-Host Disease and Oral Health ...
This review provides a practical and concise approach to the diagnosis and management of oral health needs in pediatric and adult alloHCT recipients
Dental Cleaning to Prevent Chronic Graft-Versus-Host ...
This clinical trial evaluates the feasibility and effectiveness of a post-transplant dental cleaning for the prevention of chronic graft versus host disease ...
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