- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439478
Dental Safety Profile of High-Dose Radioiodine Therapy
November 13, 2007 updated by: University Hospital, Basel, Switzerland
The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer
We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.
Study Overview
Detailed Description
Sialadenitis and xerostomia are the most frequent adverse events of high-dose radioiodine therapy.
Saliva has vital functions in maintaining periodontal and oral health.
Therefore, xerostomia not only impairs quality of life permanently, but may also increase the risk of caries and tooth extractions.
Nevertheless, despite more than 6 decades of radioiodine therapy for thyroid cancer, large studies on long-term oral adverse events are still lacking.
In the present study, we investigate the influence of high-dose radioiodine therapy on the long-term oral health.
Study Type
Observational
Enrollment
202
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4031
- University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- histologically confirmed differentiated thyroid cancer
- status after total thyroidectomy
- status after subsequent high-dose radioiodine treatment
- regular follow-up by a board-certified dentist
- a minimum follow-up of 1 year after radioiodine therapy.
Exclusion Criteria:
- anaplastic thyroid cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Beat Müller, MD, Division of Endocrinology, University Hospital Basel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
February 22, 2007
First Submitted That Met QC Criteria
February 22, 2007
First Posted (Estimate)
February 23, 2007
Study Record Updates
Last Update Posted (Estimate)
November 14, 2007
Last Update Submitted That Met QC Criteria
November 13, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 171074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.