Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study (RadboudStem)

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 Overview

• Status: Enrolling by invitation
• Conditions: Stem Cell Transplant Complications; Oral Complication
• Intervention / Treatment: Procedure: Haematopoietic stem cell transplantation

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Netherlands
  • Nijmegen, Netherlands, 6525 EX
    • Radboudumc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Allogeneic HSCT recipients treated at Radboudumc

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 26, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022-13654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No