Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study

NCT05595070 | Unknown

• 1 other identifier: 2022-13654
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Stem Cell Transplant Complications; Oral Complication

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Periodontal Epithelial Surface Area

  Change from baseline (pre-HSCT) up to 24 months after HSCT

• Periodontal Inflamed Surface Area

  Change from baseline (pre-HSCT) up to 24 months after HSCT

• Xerostomia

  Change from baseline (pre-HSCT) up to 24 months after HSCT

• Cariesactivity

  Up to 24 months after HSCT

• Oral chronic Graft-versus-Host Disease

  Up to 24 months after HSCT

Interventions

Haematopoietic stem cell transplantation PROCEDURE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allogeneic HSCT recipients treated at Radboudumc

You may qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6525 EX, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 26, 2022
• Study Start: April 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

NL (1)