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Histological and Volumetric Evaluation of Customized Allograft Bone Blocks

NCT05937035 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-04-30

No results posted yet for this study

Summary

Customized bone blocks need CBCT and digital software to design the block needed to rehabilitate. Some advantages are reduced surgical time and better adaptation of the graft, leading to less complications.

Objectives: The primary aim of this study is to determine the bone regeneration capacity through a histological study and the bone volumetric changes of allograft bone blocks in the posterior site of the mandible. The secondary outcome will be to assess the survival and success rate of dental implants placed in the allograft regenerated area.

Materials and Methods: After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.

Conditions

  • Alveolar Bone Resorption
  • Graft Overgrowth
  • Resorption of Bone Graft
  • Graft Complication
  • Block

Interventions

PROCEDURE

Customized allogenic bone block surgery

After studying the CBCT to regenerate the posterior sites of the mandible, the investigators will design CAD/CAM freeze- dried bone allograft to fit exactly on the defect morphology that the patients present. A full thickness flap will be released to have a correct access of the defects. Releasing incisions will be performed to achieve the correct closure of the flap. The sterile blocks have to fit perfectly on the defect and fixed by screws. Covered with resorbable membranes fixed with pines and suture. 4 months later, photographs, periapical xrays digital impressions and 2nd CBCTwill be performed. During the implant surgery, a bone trephine will be removed and sent into a Laboratory to make a histological study of the bone block for histomorphometry. After 3 months, second-stage surgery and healing caps will be placed if needed. Impressions will be taken 2 weeks after to perform the final crowns.

Sponsors & Collaborators

  • Universitat Internacional de Catalunya

    lead OTHER

Principal Investigators

  • JORDI GARGALLO-ALBIOL · Universitat Internacional de Catalunya

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-25
Primary Completion
2024-09-25
Completion
2025-07-25

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05937035 on ClinicalTrials.gov