This is a prospective, multicentre, parallel-group, randomized controlled, single blinded (participant) trial aims to compare the investigational medical device with standard of care in dental treatment addressing the preservation of bone loss after tooth extraction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
The intervention will include tooth extraction and GBR procedure. After clinical and radiographic assessment, local anaesthesia is applied. The dentist performs atraumatic extraction, cleans the socket, places investigational device (first arm) or standard of care (second arm) and applies gauze for hemostasis. The patient is given post-operative care instructions. After recovery the first and second stage of implantation will be performed.
Indywidualna Praktyka Stomatologiczna Marek Śmielecki
Gniezno, Poland
Medicare
Mińsk Mazowiecki, Poland
Stomatologia Niteckie Sp. z o.o.
Tychy, Poland
Rafał Dobrakowski Dentysta
Wroclaw, Poland
Evaluation of quantify the new bone formation via histomorphometric analysis following tooth extraction with GBR procedure.
A new bone formation assesses via histomorphometric evaluation.
Time frame: 6 months
Evaluation of (serious) adverse events (S)AEs.
Number of (S)AEs
Time frame: 13 months
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