Stem Cell Transplant ComplicationsRadboudStemNCT05595070
Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
An observational study of Stem Cell Transplant Complications and Oral Complication, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stem Cell Transplant Complications, Oral Complication
- What is being tested?
- Haematopoietic stem cell transplantation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Allogeneic HSCT recipients treated at Radboudumc
Who may be able to join
- 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
Who cannot join
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Being tested
- Haematopoietic stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haematopoietic stem cell transplantationProcedure or surgery
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 being measured
The primary outcome is the main question the study is designed to answer.
Number of teeth
Number of teeth (range 0 - 32)
Measured: Change from baseline (pre-HSCT) up to 24 months after HSCT
Number of restorations
Total number of restored tooth surfaces
Measured: Change from baseline (pre-HSCT) up to 24 months after HSCT
Pocket probing depth
Pocket probing depth at 6 sites per tooth in millimetres
Measured: 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
Measured: 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
Measured: Change from baseline (pre-HSCT) up to 24 months after HSCT
Unstimulated and chewing stimulated salivary pH
Whole mouth saliva, measured with pH strips
Measured: Change from baseline (pre-HSCT) up to 24 months after HSCT
Secondary outcomes (8)
Periodontal Epithelial Surface Area
The root surface area in square millimetres affected by attachment loss
Measured: 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
Measured: Change from baseline (pre-HSCT) up to 24 months after HSCT
Xerostomia
Subjective oral dryness measured by Xerostomia Inventory questionnaire
Measured: 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
Measured: 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
Measured: Up to 24 months after HSCT
Extractions
Total number of removed teeth (range 0 - 32)
Measured: 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
Measured: 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
Measured: Between baseline (pre-HSCT) and up to 24 months after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start1 Apr 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell Transplant ComplicationsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595070
- Sponsor's protocol ID
- 2022-13654
- Acronym
- RadboudStem
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 26 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Complications After Haematopoietic Stem Cell Transplantation: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05595070
- Acronym / sponsor ID
- RadboudStem / 2022-13654
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Allogeneic HSCT recipients treated at Radboudumc
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haematopoietic stem cell transplantationHaematopoietic 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). | Procedure or surgery | – |
Primary outcome
Number of teeth
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Number of teeth (range 0 - 32)
Number of restorations
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Total number of restored tooth surfaces
Pocket probing depth
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Pocket probing depth at 6 sites per tooth in millimetres
Bleeding on probing
Time frame: 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
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Whole mouth saliva, measured in mL/min
Unstimulated and chewing stimulated salivary pH
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Whole mouth saliva, measured with pH strips
8 secondary outcomes
Periodontal Epithelial Surface Area
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Periodontal Inflamed Surface Area
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Xerostomia
Time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT
Cariesactivity
Time frame: Up to 24 months after HSCT
Oral chronic Graft-versus-Host Disease
Time frame: Up to 24 months after HSCT
Extractions
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Periodontal care
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Preventive measures
Time frame: Between baseline (pre-HSCT) and up to 24 months after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Stem Cell Transplant Complications
Active, not recruitingPhase 2
MT2013-31: Allo HCT for Metabolic Disorders and Severe Osteopetrosis
Mucopolysaccharidosis Disorders, Hurler Syndrome
Active, not recruitingObservational study
Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease
Bone Marrow Transplant Complications
Not yet recruitingPhase 1
Expanded Donor Stem Cells for Poor Graft Function After Stem Cell Transplantation in Children
Poor Graft Function, Hematopoietic Stem Cell Transplantation Complications
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Not yet recruitingObservational study
Assessing the Incidence of Transplant Associated Thrombotic Microangiopathy (TA-TMA) in Adult Patients Undergoing Allogeneic Stem Cell Transplant (SCT)
Transplant Associated Microangiopathy TAM, Transplant Complication
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplant Complications and Oral Complication, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of teeth (time frame: Change from baseline (pre-HSCT) up to 24 months after HSCT). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.