Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Study Overview
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Brief Summary
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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.

Official Title
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Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Conditions
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Stem Cell Transplant Complications, Oral Complication

Intervention / Treatment
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* Procedure: Haematopoietic stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: 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).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of teeth | Number of teeth (range 0 - 32) | Change from baseline (pre-HSCT) up to 24 months after HSCT | 
| Number of restorations | Total number of restored tooth surfaces | Change from baseline (pre-HSCT) up to 24 months after HSCT | 
| Pocket probing depth | Pocket probing depth at 6 sites per tooth in millimetres | 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 | 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 | Change from baseline (pre-HSCT) up to 24 months after HSCT | 
| Unstimulated and chewing stimulated salivary pH | Whole mouth saliva, measured with pH strips | Change from baseline (pre-HSCT) up to 24 months after HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periodontal Epithelial Surface Area | The root surface area in square millimetres affected by attachment loss | 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 | Change from baseline (pre-HSCT) up to 24 months after HSCT | 
| Xerostomia | Subjective oral dryness measured by Xerostomia Inventory questionnaire | 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 | 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 | Up to 24 months after HSCT | 
| Extractions | Total number of removed teeth (range 0 - 32) | 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 | 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 | Between baseline (pre-HSCT) and up to 24 months after HSCT |