Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Dental Safety Profile of High-Dose Radioiodine Therapy

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00439478
First received: February 22, 2007
Last updated: November 13, 2007
Last verified: October 2007
  Purpose

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


Condition Intervention Phase
Thyroid Cancer
Drug: Radioiodine
Phase 4

Study Type: Observational
Official Title: The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Estimated Enrollment: 202
Study Start Date: September 2004
Study Completion Date: September 2006
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439478

Locations
Switzerland
University Hospital
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Beat Müller, MD Division of Endocrinology, University Hospital Basel
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00439478     History of Changes
Other Study ID Numbers: 171074
Study First Received: February 22, 2007
Last Updated: November 13, 2007
Health Authority: Switzerland: Ethikkommission

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

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

ClinicalTrials.gov processed this record on November 27, 2014