Oral Complication, Stem Cell Transplant Complications
Conditions
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.
Interventions
PROCEDUREHaematopoietic 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).
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of teeth | Change from baseline (pre-HSCT) up to 24 months after HSCT | Number of teeth (range 0 - 32) |
| Number of restorations | Change from baseline (pre-HSCT) up to 24 months after HSCT | Total number of restored tooth surfaces |
| Pocket probing depth | Change from baseline (pre-HSCT) up to 24 months after HSCT | Pocket probing depth at 6 sites per tooth in millimetres |
| Bleeding on probing | Change from baseline (pre-HSCT) up to 24 months after HSCT | Profound bleeding on probing at 6 sites per tooth as yes or no |
| Unstimulated and chewing stimulated salivary flow rate | Change from baseline (pre-HSCT) up to 24 months after HSCT | Whole mouth saliva, measured in mL/min |
| Unstimulated and chewing stimulated salivary pH | Change from baseline (pre-HSCT) up to 24 months after HSCT | Whole mouth saliva, measured with pH strips |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Periodontal care | Between baseline (pre-HSCT) and up to 24 months after HSCT | Number of participants per type of periodontal care, categorised in sub- and supragingival cleaning, subgingival cleaning, no cleaning |
| Periodontal Epithelial Surface Area | Change from baseline (pre-HSCT) up to 24 months after HSCT | The root surface area in square millimetres affected by attachment loss |
| Preventive measures | Between baseline (pre-HSCT) and up to 24 months after HSCT | Number of participants per type of preventive measure as fluoride varnish and oral hygiene instructions |
| Periodontal Inflamed Surface Area | Change from baseline (pre-HSCT) up to 24 months after HSCT | The root surface area in square millimetres affected by attachment loss and inflamed periodontal tissue |
| Xerostomia | Change from baseline (pre-HSCT) up to 24 months after HSCT | Subjective oral dryness measured by Xerostomia Inventory questionnaire |
| Cariesactivity | Up to 24 months after HSCT | Likelihood for development of new caries lesions based on notes recorded by the dentist |
| Oral chronic Graft-versus-Host Disease | Up to 24 months after HSCT | Assessed with National Institute of Health Oral Mucosal Score (range 0 - 15), higher score means more severe oral manifestations of oral chronic Graft-versus-Host Disease |
| Extractions | Between baseline (pre-HSCT) and up to 24 months after HSCT | Total number of removed teeth (range 0 - 32) |
Countries
Netherlands
Outcome results
None listed