Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study (RadboudStem)

Radboud University Medical Center

Status: Invitation-only

Conditions: Stem Cell Transplant Complications; Oral Complication

Treatments: Procedure: Haematopoietic stem cell transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT05595070

2022-13654

Details and patient eligibility

About

Haematopoietic stem cell transplantation (HSCT) is a potentially lifesaving treatment option for various diseases. It involves infusion of stem cells after a conditioning regimen of chemotherapy with or without total body irradiation. There is a concern that HSCT and accompanying treatments may increase the risk for oral complications. Nevertheless, longitudinal studies measuring oral health before and after HSCT are scarce. Hence, we formulated the following research question:

In adult HSCT recipients, do oral health parameters change from baseline (pre-HSCT) to 3 - 24 months post-HSCT, and is the type of conditioning regimen associated with this change in oral health parameters?

To answer this research question, we will use data from the electronic health records of the Radboudumc (Epic and Dentium). We will include at least seventy-five adult patients who are examined both before and after HSCT at the department of Dentistry (Radboudumc) as part of an oral care program. The following oral health parameters were assessed: status praesens, pocket probing depth, bleeding on probing, periodontal epithelial surface area, periodontal inflamed surface area, xerostomia, unstimulated and stimulated salivary flow rate and pH, cariesactivity, oral chronic Graft-versus-Host Disease and dental treatments.

Patients were subjected to different regimens in preparation for HSCT, namely myeloablative, reduced intensity or non-myeloablative conditioning. To estimate the association between conditioning regimen and the change in oral health parameters, we will use mixed effects models with random effects, adjusted for potential confounders. Results will be reported as regression coefficients with corresponding 95% confidence intervals.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Allogeneic HSCT between 2013 and 2021 at Radboudumc
• Oral focal screening before HSCT, and at least one oral examination after HSCT performed at Department of Dentistry, Radboudumc
• Informed consent

Exclusion criteria

• Not meeting the inclusion criteria