30
Participants
Start Date
September 29, 2025
Primary Completion Date
September 1, 2028
Study Completion Date
September 1, 2033
Bone augmentation using an autologous bone block
"* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.~* In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery.~* The block is fixed to the recipient site with two screws.~* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.~* Sutures are removed two weeks postoperatively.~* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In the case of an amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.~* Patients do not wear temporary prostheses during the healing period."
Bone augmentation using freeze-dried allograft block
"* Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap.~* In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments.~* The block is fixed to the recipient site with two screws.~* The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures.~* Sutures are removed two weeks postoperatively.~* All patients receive therapeutic-dose antibiotics: amoxicillin and clavulanic acid 2x1 for one week. In case of amoxicillin allergy, clindamycin 4x1 for seven days is administered. Non-steroid anti-inflammatory treatment with diclofenac 3x1 is also provided.~* Patients do not wear temporary prostheses during the healing period."
preoperative cone beam computed tomography (CBCT)
• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
post-operative cone beam computed tomography (CBCT)
Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
Dental implant placement
Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
Bone core biopsy
At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
Fixed dental prosthesis (FDP) fabrication
After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
Bone grafting
Freeze-dried bone allograft block
RECRUITING
Semmelweis University Department of Public Dental Health, Budapest
Semmelweis University
OTHER