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Dental Safety Profile of High-Dose Radioiodine Therapy

Primary Purpose

Thyroid Cancer

Status

Completed

Phase

Locations

Switzerland

Study Type

Observational

Intervention

Radioiodine

About this trial

This is an observational trial for Thyroid Cancer focused on measuring Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00439478

First Posted

February 22, 2007

Last Updated

November 13, 2007

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT00439478

Brief Title

Dental Safety Profile of High-Dose Radioiodine Therapy

Official Title

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

Study Type

Observational

2. Study Status

Record Verification Date

October 2007

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Thyroid Cancer

Keywords

Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia

7. Study Design

Enrollment

202 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Radioiodine

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beat Müller, MD

Organizational Affiliation

Division of Endocrinology, University Hospital Basel

Official's Role

Study Director

Facility Information:

Facility Name

University Hospital

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

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Dental Safety Profile of High-Dose Radioiodine Therapy

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