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The effects of radioiodine treatment on the occurrence of tooth cavities in patients with thyroid cancer


- candidate number15889
- NTR NumberNTR4353
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-dec-2013
- Secondary IDsNL45875.042.13 
- Public TitleThe effects of radioiodine treatment on the occurrence of tooth cavities in patients with thyroid cancer
- Scientific TitleThe effects of radioiodine treatment on dental caries incidence in patients with differentiated thyroid carcinoma
- ACRONYMN/A
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedTooth 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 receivedno
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 1-mrt-2014
- planned closingdate
- Target number of participants100
- InterventionsObservational 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 outcomeIncident 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.
- TimepointsCarious 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESProf. dr. T.P. Links
- CONTACT for SCIENTIFIC QUERIESProf. dr. T.P. Links
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD16-dec-2013 - 12-feb-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl