|- candidate number||15889|
|- NTR Number||NTR4353|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-dec-2013|
|- Secondary IDs||NL45875.042.13 |
|- Public Title||The effects of radioiodine treatment on the occurrence of tooth cavities in patients with thyroid cancer|
|- Scientific Title||The effects of radioiodine treatment on dental caries incidence in patients with differentiated thyroid carcinoma|
|- Healt Condition(s) or Problem(s) studied||Tooth cavities|
|- Inclusion criteria||- age at time of the first I131 treatment is at least 26 years|
- the patient is diagnosed with DTC at least 4 years ago
- the patient has been treated with I131
- the patient visits a dentist and is dentate at the time of I131 treatment
- the subject gives written informed consent for study participation
|- Exclusion criteria||- history of Sjögren’s syndrome or other salivary gland disease affecting salivary gland function |
- the patient switched dentist in the period of 4 years before and 4 years after the first radioiodine therapy, with no (complete) transfer of the dental record.
- the patient didn’t visit his/her dentist in the in the period of 4 years before and 4 years after radioiodine therapy.
- the patient is mentally incapacitated
|- mec approval received||no|
|- multicenter trial||no|
|- planned startdate ||1-mrt-2014|
|- planned closingdate|
|- Target number of participants||100|
|- Interventions||Observational study.|
Carious lesions will be scored from the dental record.
The patient visits the outpatient clinic once for a study visit. During this visit, the patient completes questionnaires, saliva is collected, and the teeth and the periodontium are inspected.
|- Primary outcome||Incident dental caries lesions, extracted from the dental record (includes number of caries restorations, tooth extractions and documented carious lesions) |
|- Secondary outcome||- Cumulative I131 dose |
- Number of I131 therapies
- Xerostomia and oral hygiene questionnaire scores
- Unstimulated and chewing stimulated whole saliva flow rates and pH
- Site of carious lesions
- Dutch Periodontal Screening Index (DPSI) score.
|- Timepoints||Carious lesions will be scored from the dental record in the period of 4 years before DTC diagnosis until the last dentist visit.
The patient visits the outpatient clinic once for a study visit (this is at least 4 years after DTC diagnosis)
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. T.P. Links|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. T.P. Links|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|- Brief summary||N/A|
|- Main changes (audit trail)|
|- RECORD||16-dec-2013 - 12-feb-2014|