RadboudStem: Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
- 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)
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Allogeneic HSCT between 2013 and 2021 at Radboudumc
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Radboudumc | Nijmegen | Netherlands | 6525 EX |
Sponsors and Collaborators
- Radboud University Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-13654