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Recruiting NCT07104370

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

No phase Interventional Edentulous Alveolar Ridge Edentulous Alveolar Ridge Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone augmentation using an autologous bone block, Bone augmentation using freeze-dried allograft block, preoperative cone beam computed tomography (CBCT), post-operative cone beam computed tomography (CBCT).
Who it may be relevant to
Registry conditions: Edentulous Alveolar Ridge, Edentulous Alveolar Ridge Atrophy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial

Overview

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.

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 postopera
  • 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 ther
  • 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

Primary outcome measures

  • Success of the bone augmentation [Time frame: 3 months]
  • Success of the dental implants [Time frame: 3 months]
  • Success of the implant-borne prostheses [Time frame: 5 years]
Secondary outcome measures (11)
  • Hisomorphometry: Percent of residual bone graft particles [Time frame: 3-6 months]
  • Hisomorphometry: Percent of newly formed bone [Time frame: 3-6 months]
  • Hisomorphometry: Percent of bone marrow [Time frame: 3-6 months]
  • Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples [Time frame: 3-6 months]
  • Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples [Time frame: 3-6 months]
  • Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples. [Time frame: 3-6 months]
  • Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples. [Time frame: 3-6 months]
  • Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples. [Time frame: 3-6 months]
  • Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples. [Time frame: 3-6 months]
  • Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples. [Time frame: 3-6 months]
  • Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples. [Time frame: 3-6 months]

Eligibility criteria

Inclusion criteria

  • over 18 years old
  • require lateral augmentation for implant rehabilitation

Exclusion criteria

  • Smoking
  • Pregnancy
  • Poor oral hygiene
  • Failure to attend follow-up visits
  • Therapeutic-dose irradiation to the head and neck region
  • Local bone tumors, cysts, or inflammatory processes
  • Decompensated systemic diseases contraindicate surgery
  • Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
  • Psychiatric disorders contraindicate implant rehabilitation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hungary · 1 center
  • Semmelweis University Department of Public Dental Health — Budapest

Identifiers

NCT: NCT07104370 · SEDCD45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗