HSCT recipients are at risk for developing oral complications five years after transplantation.
ID
Bron
Verkorte titel
Aandoening
Dental and oral diseases
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Outcomes are assessed once during study visit.
Periodontal disease: full pocket depth index will be registered at six surfaces of each tooth. Bleeding on probing will be noted (Y/N) for each surface. The percentage of bleeding on probing will be reported. Gingival recession will be registered for two surfaces (buccal and lingual) on each tooth as the distance between gingival margin and cemento-enamel junction. Furcation accessibility of (pre)molars will be noted, as well as tooth mobility of all teeth.
Dental caries: the ICDAS-II will be used to qualitatively asses caries. All tooth surfaces will be scored and scores ≥2 will be listed:
2: distinct visual change in enamel
3: localized enamel breakdown (without clinical visual signs of dental involvement)
4: underlying dark shadow from dentin
5: distinct cavity with visible dentin
6: extensive distinct cavity with visible dentin
Root caries
7: discoloration but no cavitation
8: discoloration with cavitation
Caries history and necessary treatments due to caries in the past 10 years will be assessed with the help of general dentists’ charts including radiographs.
Achtergrond van het onderzoek
Rationale: the oral cavity is a common site for complications related to hematopoietic stem cell transplantation (HSCT). The previously performed multicenter study “Oral Complications in patients treated with hematopoietic stem cell transplantation” with the acronym Orastem/HOME(performed in RADBOUD UMC and AMSTERDAM UMC, NL52117.018.15 studynumber 2015_087) focused on oral complications up to 18 months after HSCT. However, there is a need for long-term follow-up of HSCT recipients to evaluate the development of periodontal disease and dental caries. The knowledge on long-term oral complications andtheir risk indicators, clinical characteristics, and consequences is inadequate. The present observational study with the acronym ‘HOME2’ will be performed to attenuate this gap of knowledge. We anticipate that the results of ‘HOME2’ will provide a scientific base for the development of individualized preventive strategies.
Objective: to describe the long-term oral complications after HSCT, and evaluate periodontal changes and caries progression in HSCT recipients five years after transplantation.
Study design: one additional follow-up visit to the prospective observational Orastem/HOME study.
Study population: HSCT survivors who were included in the previously performed Orastem/H-OME study (patients ≥ 18 years diagnosed with a malignancy who received full or reduced intensity conditioning therapy followed by autologous or allogeneic HSCT between 2015 and 2018).
Main study parameters/endpoints: periodontal changes and caries progression five years post-HSCT.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden for patients of this observational study is mild. Patients are asked to visit the site once, which is located next to the hospital where the recipients visit their doctor for regular check-ups. During the site visit, the study procedure includes an oral examination, measuring salivary flow rate and pH and completion of questionnaires. There are no direct risks or benefits for participating subjects in this study. The anticipated knowledge gained from this study will help to improve future supportive care protocols for HSCT recipients.
Doel van het onderzoek
HSCT recipients are at risk for developing oral complications five years after transplantation.
Onderzoeksopzet
One
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Member of the closed cohort of the Orastem/H-OME study
- Able and willing to provide written and dated informed consent prior to any study specific procedure
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who received a second autologous or allogeneic HSCT
- Patients unable to give written and dated informed consent
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9825 |
| Ander register | CMO : 2021-12963 |