Actively Recruiting
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
Led by National Institute of Dental and Craniofacial Research (NIDCR) · Updated on 2026-04-14
500
Participants Needed
1
Research Sites
954 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: This study follows people who have had, or will soon have, a transplant using stem cells from another person. This is known as an allogeneic hematopoietic stem cell transplant (HSCT). Graft-versus-host disease (cGVHD) can happen after HSCT. cGVHD can cause mouth problems and more serious issues. Researchers want to study changes in the mouth that might indicate cGVHD. Objective: To identify cGVHD in the mouth and better understand the development, treatment, and progress of post-transplant changes in the mouth. Eligibility: Adults at least 18 years old who will soon undergo HSCT or have had one in the past 3 years Healthy adults at least 18 years old Design: All participants will have a screening visit and baseline visit. They will last 60-90 minutes. Over these two visits, participants will have: Medical and dental history Dental exam. Questions about their eating habits and general health Blood drawn through a needle in the arm Vital signs taken Pictures of their mouth and lips taken Questions about their oral health, including about pain, sensitivity, or dryness Saliva samples taken. Participants will spit into a sterile plastic tube. Swabs taken of the mouth and some of the saliva, plaque, and fluid from the spaces between teeth and gums. Participants may also have: A piece of skin taken (biopsy) from the inner lining of the cheeks A piece of skin taken (biopsy) from the lower lip Dental X-rays Urine pregnancy test Most participants will have at least 7 study visits over 3 years. They will meet with a dentist and repeat baseline tests.
CONDITIONS
Official Title
Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be at least 18 years old
- Scheduled to undergo allogeneic HSCT at the NIH or have had one within the past 3 years
- Willing to participate in saliva and oral swab collections and complete patient-reported outcome forms
- Able to return to the NIH Dental Clinic for scheduled evaluations
- Able to understand and provide written informed consent
- Healthy volunteers must be willing to undergo oral exams, saliva and swab collections, and oral biopsies
- Healthy volunteers may be age- and/or sex-matched with transplant patients
- Healthy volunteers in the longitudinal cohort must be willing to return for visits over 1 year
You will not qualify if you...
- Pregnant individuals are excluded
- Transplant patients may be excluded if the NIH transplant team considers participation unsafe or not in their best interest
- Healthy volunteers with acute oral infections requiring multiple dental visits or specialist referral are excluded
- Healthy volunteers with uncontrolled chronic disease, active systemic illness, ongoing orthodontic treatment, frequent opportunistic infections, autoimmune disease, immunosuppressive medication use, or prior transplants are excluded
- Healthy volunteers taking medications or therapies known or suspected to affect the oral microbiome are excluded
- Healthy volunteers planning pregnancy within the next year or refusing oral biopsies are excluded from the longitudinal cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Licia R Masuch
CONTACT
J
Jacqueline W Mays, D.D.S.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here