Dental Safety Profile of High-Dose Radioiodine Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439478
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : November 14, 2007
Information provided by:
University Hospital, Basel, Switzerland

Brief Summary:
We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.

Condition or disease Intervention/treatment
Thyroid Cancer Drug: Radioiodine

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 participants
Official Title: The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer
Study Start Date : September 2004
Actual Study Completion Date : September 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439478

University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Study Director: Beat Müller, MD Division of Endocrinology, University Hospital Basel Identifier: NCT00439478     History of Changes
Other Study ID Numbers: 171074
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: October 2007

Keywords provided by University Hospital, Basel, Switzerland:
Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms