Health TrialsbyHealthPanel

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

ConditionsEdentulous Alveolar RidgeEdentulous Alveolar Ridge Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSemmelweis University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

over 18 years old

require lateral augmentation for implant rehabilitation

Disqualifiers

Smoking

Pregnancy

Poor oral hygiene

Failure to attend follow-up visits

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bone augmentation using an autologous bone block

    Procedure/Surgery

    * 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

    Procedure/Surgery

    * 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)

    Diagnostic test

    • 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)

    Diagnostic test

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

  • Dental implant placement

    Procedure/Surgery

    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

    Diagnostic test

    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

    Procedure/Surgery

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

  • Bone grafting

    Device

    Freeze-dried bone allograft block

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Freeze-dried allograft bone blockExperimental treatment 7 interventions
Group B: Autogenous bone blockActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
3 months
2

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

Time frame
3 months
3

Success of the implant-borne prostheses

Prostheses with four or fewer complications (screw loosening, decementation, chipping) that could be treated chairside.

Time frame
5 years

Secondary outcomes

1

Hisomorphometry: Percent of residual bone graft particles

The percentage of residual bone graft particle area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)

Time frame
3-6 months
2

Hisomorphometry: Percent of newly formed bone

The percentage of newly formed bone area is measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%).

Time frame
3-6 months
3

Hisomorphometry: Percent of bone marrow

The percentage of bone marrow area measured on the representative sections prepared from the bone core biopsy samples. Unit: percent (%)

Time frame
3-6 months
4

Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples

Relative volume of calcified tissue in the selected volume. Unit: none

Time frame
3-6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Semmelweis University

Lead sponsor

Source ClinicalTrials.gov
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