Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Stem Cell Transplant Complications Clinical Trial

— RadboudStem  

Official title:

Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05595070
• Other study ID #: 2022-13654
• Status: Enrolling by invitation
• Start date: April 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Complication
• Stem Cell Transplant Complications

Intervention

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).

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of teeth	Number of teeth (range 0 - 32)	Change from baseline (pre-HSCT) up to 24 months after HSCT
Primary	Number of restorations	Total number of restored tooth surfaces	Change from baseline (pre-HSCT) up to 24 months after HSCT
Primary	Pocket probing depth	Pocket probing depth at 6 sites per tooth in millimetres	Change from baseline (pre-HSCT) up to 24 months after HSCT
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Xerostomia	Subjective oral dryness measured by Xerostomia Inventory questionnaire	Change from baseline (pre-HSCT) up to 24 months after HSCT
Secondary	Cariesactivity	Likelihood for development of new caries lesions based on notes recorded by the dentist	Up to 24 months after HSCT
Secondary	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
Secondary	Extractions	Total number of removed teeth (range 0 - 32)	Between baseline (pre-HSCT) and up to 24 months after HSCT
Secondary	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
Secondary	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