Actively Recruiting
Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial
Led by Semmelweis University · Updated on 2025-10-03
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating bone augmentation techniques to improve dental implant success in patients with severe bone loss in the jaw after tooth loss. The study compares two types of bone graft materials: freeze-dried bone allograft blocks and autologous bone blocks harvested from the patient's own mandible. The goal is to evaluate which method better supports bone regeneration and implant rehabilitation by examining bone quality and implant outcomes. Participants will undergo lateral jaw augmentation surgery using either a freeze-dried bone allograft block or an autologous bone block. Both procedures involve local anesthesia, incisions to prepare the surgical site, and fixation of the bone blocks with screws. After surgery, patients receive antibiotics and anti-inflammatory medication. Three months after augmentation, dental implants are placed non-submerged into the augmented bone, and bone core biopsies are taken for detailed analysis. Fixed dental prostheses are delivered three months following implant placement. Throughout the study, participants will have cone beam computed tomography (CBCT) scans before and after augmentation to assess bone changes. Researchers will conduct histomorphometric and microCT analyses on bone samples to measure bone volume and quality. The primary outcomes include the success of bone augmentation and dental implants within three months and the success of implant-supported prostheses over five years. Participants are monitored closely with follow-up visits to evaluate healing and implant function.
CONDITIONS
Brief Title
Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be over 18 years old
- Require lateral bone augmentation for dental implant rehabilitation
You will not qualify if you...
- Current smoking
- Pregnancy
- Poor oral hygiene
- Failure to attend follow-up visits
- Therapeutic-dose irradiation to the head and neck region
- Presence of local bone tumors, cysts, or inflammatory processes
- Decompensated systemic diseases that contraindicate surgery
- Use of medications affecting bone metabolism such as steroids, bisphosphonates, RANKL inhibitors, or VEGF antagonists
- Psychiatric disorders that contraindicate implant rehabilitation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks or until suture removal
Participants undergo bone augmentation surgery using either a freeze-dried allograft bone block or an autologous bone block harvested from the retromolar area. This includes local anesthesia, flap preparation, graft fixation with screws, and wound closure. Participants receive antibiotics and anti-inflammatory medications and do not wear temporary prostheses during healing.
1 surgical visit and 1 suture removal visit
Duration - Approximately 3 months
Participants receive post-operative care including a CBCT scan to assess bone quantity and quality. After a 3-month healing period, dental implants are placed, and a bone core biopsy is taken from the augmented bone for analysis.
1 post-operative imaging visit and 1 dental implant placement visit
Duration - Up to 5 years
After dental implant placement, participants receive a fixed dental prosthesis 3 months later and are monitored for success of the implant-borne prostheses over 5 years.
1 prosthesis delivery visit and periodic follow-up visits
Trial Site Locations
Total: 1 location
1
Semmelweis University Department of Public Dental Health
Budapest, Hungary, Hungary, 1088
Actively Recruiting
Research Team
C
Csilla Szerencse, DMD, MDS
M
Márton Kivovics, DMD, MDS, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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