The study is intended to verify a newly developed method to measure the thickness of cranial soft tissue. In the study, a high-resolution MRI scan is used as ground truth for a laser scan of the forehead. The laser scan is acquired point by point with a prototype scanning unit developed at the University of Luebeck's Institute for Robotics. The measured tissue thickness using the near-infrared scanning approach is validated against the ground truth obtained by the MRI scan. The average accuracy of the reconstruction method is then computed over all subjects from the individual study arms. The required laser intensity and exposure time as well as the achieved measurement accuracy is evaluated with respect to the different skin types of the test subjects. Correlation between these features and the skin type according to the Fitzpatrick scale will be computed. For 1/3 of the subjects, the laser and MRI scans are repeated after 2 and 8 weeks. The results of the scans are compared and time dependency is analysed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
25
Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
A near-infrared laser scan of the subject's forehead is acquired
A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
Clinic for Maxillofacial Surgery of the University Hospital Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
ACTIVE_NOT_RECRUITINGUniversity of Luebeck, Institute for Robotics
Lübeck, Schleswig-Holstein, Germany
RECRUITINGAverage accuracy of tissue thickness measurement method [mm]
Time frame: up to 6 months
System dependency on skin color - required intensity
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required laser intensity \[mW\])
Time frame: up to 6 months
Long-term stability of measured features - accuracy
Change in measurement accuracy \[mm\]
Time frame: up to 8 months
Long-term stability of measured features - required intensity
Change in required laser intensity \[mW\]
Time frame: up to 8 months
Long-term stability of measured features - required exposure time
Change in required exposure time \[ms\]
Time frame: up to 8 months
System dependency on skin color - accuracy
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (accuracy of tissue thickness measurement \[mm\])
Time frame: up to 6 months
System dependency on skin color - exposure time
Correlation between skin types (according to the Fitzpatrick scale) and the outcome (required exposure time \[ms\])
Time frame: up to 6 months
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