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Chronic Graft-versus-Host Disease in the Oral Cavity of Patients Following Allogeneic Hematopoietic Stem Cell Transplant and Including Healthy Controls

NCT03602599 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-04-14

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

    lead NIH

Principal Investigators

  • Jacqueline W Mays, D.D.S. · National Institute of Dental and Craniofacial Research (NIDCR)

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2037-03-03
Completion
2037-03-03

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602599 on ClinicalTrials.gov