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.
Study Type
OBSERVATIONAL
Enrollment
200
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).
Radboudumc
Nijmegen, Netherlands
Number of teeth
Number of teeth (range 0 - 32)
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Number of restorations
Total number of restored tooth surfaces
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Pocket probing depth
Pocket probing depth at 6 sites per tooth in millimetres
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Bleeding on probing
Profound bleeding on probing at 6 sites per tooth as yes or no
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Unstimulated and chewing stimulated salivary flow rate
Whole mouth saliva, measured in mL/min
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Unstimulated and chewing stimulated salivary pH
Whole mouth saliva, measured with pH strips
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Periodontal Epithelial Surface Area
The root surface area in square millimetres affected by attachment loss
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Periodontal Inflamed Surface Area
The root surface area in square millimetres affected by attachment loss and inflamed periodontal tissue
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Xerostomia
Subjective oral dryness measured by Xerostomia Inventory questionnaire
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Cariesactivity
Likelihood for development of new caries lesions based on notes recorded by the dentist
Time frame: Up to 24 months after HSCT
Oral chronic Graft-versus-Host Disease
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
Time frame: Up to 24 months after HSCT
Extractions
Total number of removed teeth (range 0 - 32)
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Periodontal care
Number of participants per type of periodontal care, categorised in sub- and supragingival cleaning, subgingival cleaning, no cleaning
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Preventive measures
Number of participants per type of preventive measure as fluoride varnish and oral hygiene instructions
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
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