Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07104370

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must be over 18 years old
  • Require lateral bone augmentation for dental implant rehabilitation
Not Eligible

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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Post-operative Follow-up

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

Follow-up

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

Loading map...

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

Similar Trials

Behavioral Comparison of Three Different Graft Materials to ...

Soft Tissue Atrophy

Actively Recruiting

1 location

Clinical Influence of Different Surface Treatments on Implan...

Edentulous Alveolar Ridge

Actively Recruiting

1 location

Soft Tissue Response to Different Restorative Materials Used...

Edentulous Alveolar Ridge

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here