Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

NCT ID: NCT05595070

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

Conditions

Stem Cell Transplant Complications; Oral Complication

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

Haematopoietic stem cell transplantation

Haematopoietic stem cell transplantation (HSCT) is widely used in the treatment of malignant and non-malignant conditions to reconstitute the immune system secondary to cytotoxic conditioning regimens. These regimens, consisting of chemotherapy with or without total body irradiation, cause severe immunosuppression prior to, during and after HSCT. Immune reconstitution takes place by infusion of stem cells either harvested from the patient (autologous HSCT) or from a donor (allogeneic HSCT).

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Radboudumc

Nijmegen, , Netherlands

Countries

Netherlands

Other Identifiers

2022-13654

Identifier Type: -

Identifier Source: org_study_id