NCT05595070: RadboudStem

Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Status unknown Last updated 26 October 2022

What this trial tests

trial testing Haematopoietic stem cell transplantation in Stem Cell Transplant Complications in 200 participants. Status unknown.

Timeline

1 April 2022

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	200
Start date	1 April 2022
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• Haematopoietic stem cell transplantation

Conditions studied

• Stem Cell Transplant Complications — all drugs for Stem Cell Transplant Complications →
• Oral Complication — all drugs for Oral Complication →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Stem Cell Transplant Complications or Oral Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Periodontal changes after haematopoietic cell transplantation and the role of conditioning regimen intensity.
   van Gennip LLA, Bulthuis MS, Hannink G, Bronkhorst EM, et al · · 2025 · PMID 40548989 · DOI 10.1007/s00520-025-09654-9