Finding answers to the folowing questions:Does 18 fluoride PET research have the potential to make a better differentiation between an active and inactive condyle in comparison to bone scintigraphy including SPECT in patients with a Unilateral…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Temporo-Mandibulaire Gewricht
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Difference of bone activity between the hyperplastic and contralateral condyle.
The results of planar and SPECT research will be compared to PET research.
Secondary outcome
Difference in vascularisation between the hyperplastic and contralateral
condyle. We'll assess if there is a higher bloodflow in the hyperplastic
condyle in comparison to the contralateral condyle.
Background summary
In Unilateral Condylar Hyperplasia (UCH), an asymmetrical development of the
mandible can be noticed, based on a unilateral persistant or renewed growth of
the condyle.
Before (surgical) correction of a mandibular asymmetry, it is mandatory to
assess whether or not the growth centre of the condyle is still active, to
prevent unnecessary surgery to the joint or on the other hand, progression of
the asymmetry after correction.
Nowadays, progression of the asymmetry is assesed by clinical and radiological
follow up, planar scintigraphy and SPECT research.
The aim of the PET study is to determine whether or not a better
differentiation between patients with or without asymmetrical bone activity in
the condyles can be made. Kwantification of 18F- uptake seems to be superior to
the semi-kwantitative methods, used in bone scintigraphy including SPECT.
In regard to the pathogenesis, which is still unknown, vascularisation of the
condyle regions will be measured.
Study objective
Finding answers to the folowing questions:
Does 18 fluoride PET research have the potential to make a better
differentiation between an active and inactive condyle in comparison to bone
scintigraphy including SPECT in patients with a Unilateral Condylar Hyperplasia
(UCH)?
Can a higher vascularisation be noticed in a condyle with persistent growth in
comparison to the contralateral side? This in regard to the unknown
pathogenesis.
Study design
Observational research
Study burden and risks
Burden: 1 artery and 1 venous line will be inserted in the lower arm. Patients
can't move during the PET scanning
Radiation dose per scan: 3 milliSievert
The radiation dose of a Dutch citizen based on radiation from the universe
during 1 year, is 2-2,5 mSv. The radiation dose due to this study seems to be
acceptable
De Boelelaan 1118
1081 HV Amsterdam
Nederland
De Boelelaan 1118
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
suspicion of progressive mandibulair asymmetry and clinical suspicion of an unilateral condylar hyperplasia.
Age 18-40 years
Exclusion criteria
Pregnancy
The inability of lying on the back during 1 hour
Nuclear or radiologic research in the year prior to this study, with a yeardose of more than 10 mSv
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11893.029.06 |