Dental Safety Profile of High-Dose Radioiodine Therapy

Thyroid Cancer Clinical Trial

Official title:

The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439478
• Other study ID #: 171074
• Status: Completed
• Phase: Phase 4
• First received: February 22, 2007
• Last updated: November 13, 2007
• Start date: September 2004
• Est. completion date: September 2006

Study information

• Verified date: October 2007
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Radioiodine

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland,