Brief Summary

After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation. Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties. The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing. The aim of the study is:

to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used,
compare the microarchitecture of the augmented bone depending on the bone graft material applied,
to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

87mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

7.9 years study duration

Study Progress9%

Sep 2025Sep 2033

First Submitted

Initial submission to the registry

July 29, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected

5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2033

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2.9 years

First QC Date

July 29, 2025

Last Update Submit

September 29, 2025

Conditions

Edentulous Alveolar Ridge Edentulous Alveolar Ridge Atrophy

Keywords

autologous boneretromolar areabone blockbone augmentationdental implantfreeze-dried bone allograft

Outcome Measures

Primary Outcomes (3)

Success of the bone augmentation
The bone augmentation surgery is successful if no inflammatory complications occur in the 3-month healing period and the bone volume is sufficient for dental implant placement.
3 months
Success of the dental implants
According to The International Congress of Oral Implantologists (ICOI) Pisa Consensus Conference. I. Success (optimum health) 1. No pain or tenderness upon function 2. 0 mobility 3. Less than 2 mm radiographic bone loss from initial surgery 4. No exudates in the patient's history II. Satisfactory survival 1. No pain on function 2. 0 mobility 3. 2-4 mm radiographic bone loss 4. No exudates in the patient's history III. Compromised survival 1. May have sensitivity to the function 2. No mobility 3. Radiographic bone loss of more than 4 mm (less than1/2 of the length of the implant body) 4. Probing depth more than 7 mm 5. May have exudates in the patient's history IV. Failure (clinical or absolute failure) Any of the following: 1. Pain on function 2. Mobility 3. Radiographic bone loss of more than 1/2 the length of the implant 4. Uncontrolled exudate 5. Implant no longer in the mouth
3 months
Success of the implant-borne prostheses
Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.
5 years

Secondary Outcomes (11)

Hisomorphometry: Percent of residual bone graft particles
3-6 months
Hisomorphometry: Percent of newly formed bone
3-6 months
Hisomorphometry: Percent of bone marrow
3-6 months
Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples
3-6 months
Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples
3-6 months
+6 more secondary outcomes

Study Arms (2)

Freeze-dried allograft bone block

EXPERIMENTAL

A freeze-dried bone allograft block is used for the lateral augmentation of the atrophied jaw.

Procedure: Bone augmentation using freeze-dried allograft blockDiagnostic Test: preoperative cone beam computed tomography (CBCT)Diagnostic Test: post-operative cone beam computed tomography (CBCT)Procedure: Dental implant placementDiagnostic Test: Bone core biopsyProcedure: Fixed dental prosthesis (FDP) fabricationDevice: Bone grafting

Autogenous bone block

ACTIVE COMPARATOR

An autogenous bone block harvested from the retromolar area of the mandible is used for the lateral augmentation of the atrophied jaw.

Procedure: Bone augmentation using an autologous bone blockDiagnostic Test: preoperative cone beam computed tomography (CBCT)Diagnostic Test: post-operative cone beam computed tomography (CBCT)Procedure: Dental implant placementDiagnostic Test: Bone core biopsyProcedure: Fixed dental prosthesis (FDP) fabrication

Interventions

Bone augmentation using an autologous bone blockPROCEDURE

* 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.

Autogenous bone block

Bone augmentation using freeze-dried allograft blockPROCEDURE

* 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.

Freeze-dried allograft bone block

preoperative cone beam computed tomography (CBCT)DIAGNOSTIC_TEST

• Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.