The effects of radioiodine treatment on caries incidence in patients with differentiated thyroid carcinoma

Completed

• Conditions: caries; cavities; tooth decay; 10043739

• Registration Number: NL-OMON50290
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

- age at time of the first I131 treatment is at least 26 years
- the patient is diagnosed with DTC at least 4 years ago
- the patient has been treated with I131
- the patient visits a dentist and is dentate at the time of I131 treatment
- the subject gives written informed consent for study participation

Exclusion Criteria

- a history of Sjögren*s syndrome or other salivary gland disease affecting
salivary gland function
- the patient switched dentist in the period of 4 years before and 4 years
after the first radioiodine therapy, with no (complete) transfer of the dental
record.
- the patient didn*t visit his/her dentist in the in the period of 4 years
before and 4 years after radioiodine therapy.
- patient is mentally incapacitated

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is difference in the rate of incident carious lesions<br /><br>before and after radioiodine therapy. Incident carious lesions are defined as<br /><br>reported new developed carious lesions in the dental record, a dental<br /><br>restoration or a tooth extraction. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters:<br /><br>1. Unstimulated and stimulated saliva pH<br /><br>2. Flow rate of unstimulated and stimulated saliva in ml/min<br /><br>3. Cumulative radioiodine dose<br /><br>4. Number of radioiodine treatments<br /><br>5. Xerostomia questionnaire score<br /><br>6. Dental care questionnaire score<br /><br>7. DPSI score (Dutch Periodontal Screening Index score)<br /><br><br /><br>Other study parameters include:<br /><br>1. Baseline characteristics: age, sex, tumour histology and TNM classification.<br /><br>2. Medication list</p><br>