Thyroid CancerNCT00439478
Dental Safety Profile of High-Dose Radioiodine Therapy
An observational study of Thyroid Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
We aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Radioiodine
- How many people
- 202 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2004to Sep 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- anaplastic thyroid cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thyroid Cancer
- Being tested
- Radioiodine
- Keywords
- Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia
- Medical subject headings
- Thyroid Neoplasms, Sialadenitis, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadioiodineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startSep 2004
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 202 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Beat Müller, MD, Study director, Division of Endocrinology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439478
- Sponsor's protocol ID
- 171074
- Status last verified
- Oct 2007
- First submitted
- 22 Feb 2007
- Last updated
- 14 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dental Safety Profile of High-Dose Radioiodine Therapy for Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00439478
- Acronym / sponsor ID
- 171074
- Conditions
- Thyroid Cancer
- Keywords
- Radioiodine, Thyroid Cancer, Sialadenitis, Xerostomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Sep 2006 (actual)
- First posted
- 23 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- anaplastic thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radioiodine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beat Müller, MD study director
Division of Endocrinology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2007.