Clinical trial NCT05595070: Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
Official title: Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stem Cell Transplant Complications
Oral Complication
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Allogeneic HSCT recipients treated at Radboudumc

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.


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

Exclusion Criteria:

* Not meeting the inclusion criteria

Primary outcomes:
measure: Number of teeth
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Number of restorations
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Pocket probing depth
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Bleeding on probing
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Unstimulated and chewing stimulated salivary flow rate
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Unstimulated and chewing stimulated salivary pH
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Secondary outcomes:
measure: Periodontal Epithelial Surface Area
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Periodontal Inflamed Surface Area
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Xerostomia
timeFrame: Change from baseline (pre-HSCT) up to 24 months after HSCT
measure: Cariesactivity
timeFrame: Up to 24 months after HSCT
measure: Oral chronic Graft-versus-Host Disease
timeFrame: Up to 24 months after HSCT
measure: Extractions
timeFrame: Between baseline (pre-HSCT) and up to 24 months after HSCT
measure: Periodontal care
timeFrame: Between baseline (pre-HSCT) and up to 24 months after HSCT
measure: Preventive measures
timeFrame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References: