The clinical study aims to assess the long-term safety and efficacy of the interventional medical device. The clinical study will enrol up to 50 patients aged 18 years and older, who meet specific inclusion and exclusion criteria designed to ensure patient safety and reliable data collection.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
GBR procedure is a technique often used in conjunction with dental implants to enhance the success and stability of the implant. This technique involves using barrier membranes to protect the bone graft or defect site from the rapid proliferation of surrounding soft tissues. In this clinical investigation resorbable, collagen membrane will be used.
Assessment of collagen membrane's - efficacy and safety.
Remnants of the collagen membrane, new blood vessels formation, and the absence of inflammation in histological results.
Time frame: 6 months after intervention
Complication rate
Complication rate assessed as the ratio patients with any complication to all patients.
Time frame: 7 days and 6 months after intervention
Change in bone dimensions
% change in horizontal bone dimensions at three subcrestal levels assessed via CBCT.
Time frame: Baseline, 6 and 12 months after intervention
VAS scale
Scale VAS for pain, swelling, bleeding. VAS scale will be used to assess satisfaction of the intervention.
Time frame: On the day of intervention and after 1, 2, 3 days. Satisfaction - on the day of intervention.
Assessment of collagen membrane's - safety.
Number of (S)AEs.
Time frame: From the beginning till the end.
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