Dental and oral diseases
Conditions
Interventions
None listed
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcomes are assessed once during study visit. Tooth loss: the number of teeth present at the 5 years dental check-up will be measured. General dentists’ charts including intra- and extraoral radiographs will be used to evaluate the reasons for extractions in the past 10 years. Oral mucosal cGVHD: oral mucosa will be inspected for oral alterations. The NIH oral cGVHD Activity Assessment will be used to assess oral cGVHD. Unstimulated and stimulated salivary flowrate and pH: patients will be asked to refrain from eating or drinking 1 hour before the collection. To collect unstimulated whole saliva, patients will be asked to spit the saliva in a preweighed plastic cup for 5 min without making any effort to increase the salivary flow. During the collection of stimulated whole saliva, patients will chew on a piece of neutral chewing gum base. After collection, samples will be weighted and flow rates estimated by assuming 1 gram of saliva equals 1 mL. The pH will be determined using pH indicator strips (pH-indicator strips 5.5 – 8.0, Hydrion, New York). Maximum mouth opening: maximum mouth opening is measured as the greatest distance between incisal edge of maxillary central incisor to the incisal edge of mandibular central incisor, when the mouth is opened as wide as possible. The patient will be asked to open as wide as possible three times. During the third attempt the interincisal distance will be measured. Oral microbiome: patients will be asked to rinse during 10 seconds with a sterile 0,9% saline solution. The rinses will be collected into sterile tubes, spun down, resuspended in sterile PBS and frozen at -80°C within 2 hours. Oral health-related quality of life and xerostomia: patients will be asked to fill in the EORTC OH-17 questionnaire. Masticatory function: patients will be asked to fill in the MFIQ questionnaire. | — |
Contacts
Public ContactLucky van Gennip
Radboudumc Dentistry
Outcome results
None listed