Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 29, 2025

Primary Completion Date

September 1, 2028

Study Completion Date

September 1, 2033

Conditions
Edentulous Alveolar RidgeEdentulous Alveolar Ridge Atrophy
Interventions
PROCEDURE

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."

PROCEDURE

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."

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

post-operative cone beam computed tomography (CBCT)

Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.

PROCEDURE

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.

DIAGNOSTIC_TEST

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.

PROCEDURE

Fixed dental prosthesis (FDP) fabrication

After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.

DEVICE

Bone grafting

Freeze-dried bone allograft block

Trial Locations (1)

1088

RECRUITING

Semmelweis University Department of Public Dental Health, Budapest

All Listed Sponsors
lead

Semmelweis University

OTHER

NCT07104370 - Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws | Biotech Hunter | Biotech Hunter