Primary Objectives 1. Evaluate whether the incidence of caries increases after radioiodine treatment as compared to the pre I131-therapy period in patients with differentiated thyroid carcinoma.Secondary Objectives 1. Evaluate whether the cumulative…
ID
Source
Brief title
Condition
- Other condition
- Thyroid gland disorders
Synonym
Health condition
caries
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is difference in the rate of incident carious lesions
before and after radioiodine therapy. Incident carious lesions are defined as
reported new developed carious lesions in the dental record, a dental
restoration or a tooth extraction.
Secondary outcome
Secondary study parameters:
1. Unstimulated and stimulated saliva pH
2. Flow rate of unstimulated and stimulated saliva in ml/min
3. Cumulative radioiodine dose
4. Number of radioiodine treatments
5. Xerostomia questionnaire score
6. Dental care questionnaire score
7. DPSI score (Dutch Periodontal Screening Index score)
Other study parameters include:
1. Baseline characteristics: age, sex, tumour histology and TNM classification.
2. Medication list
Background summary
Patients with differentiated thyroid carcinoma (DTC) have a favourable
prognosis, therefore there is a growing interest for late effects of treatment.
Radioiodine (I131) therapy is one of the standard treatment entities for DTC
patients. I131 treatment has been associated with salivary gland damage, and
many patients have complaints of a dry mouth. Except for complaints of
xerostomia, several patients in follow-up for DTC in the UMCG presented with a
highly increased incidence of caries. In these patients the caries episode
started after DTC diagnosis/I131 therapy, therefore will study the effects of
I131 treatment on the development of dental caries.
A cross-sectional study with DTC patients in follow-up for at least 4 years
will give us more guidance in the magnitude of this problem. The study can
reveal predictors to identify patients at risk for development of new carious
lesions, and contribute to prevent long-term adverse effects of treatment and
improve care for DTC survivors.
Study objective
Primary Objectives
1. Evaluate whether the incidence of caries increases after radioiodine
treatment as compared to the pre I131-therapy period in patients with
differentiated thyroid carcinoma.
Secondary Objectives
1. Evaluate whether the cumulative radioiodine dose, saliva flow rate, saliva
pH and xerostomia complaints are predictors for the development of dental
caries after radioiodine treatment in differentiated thyroid carcinoma patients.
2. Evaluate whether there is a site-specific pattern for caries in
differentiated thyroid carcinoma patients.
Study design
Cross-sectional exploratory observational study
Study burden and risks
This study is not associated with any risks for the participating patient.
Furthermore, the burden of study participation is low, as study participation
takes only 30 minutes, and study measurements take place directly after a
outpatient visit. There are no invasive measurements or interventions.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45875.042.13 |
| Other | NTR candidate number 15889 |
| OMON | NL-OMON29082 |