NCT04286334

Three-dimensional Bone Regeneration Using Custom-made Meshes With and Without Collagen Membrane

Completed NA Last updated 3 August 2022

What this trial tests

NA trial testing Bone augmentation with cad-cam laser-sintered mesh in Surgical Procedure, Unspecified in 30 participants. Completed in 1 August 2022.

Timeline

1 December 2017

Primary endpoint
1 December 2019

1 August 2022

Quick facts

Lead sponsor	GBR Academy
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 December 2017
Primary completion	1 December 2019
Estimated completion	1 August 2022
Sites	1 location across Italy

Drugs / interventions tested

• Bone augmentation with cad-cam laser-sintered mesh

Conditions studied

• Surgical Procedure, Unspecified — all drugs for Surgical Procedure, Unspecified →
• Soft Tissue Infections — all drugs for Soft Tissue Infections →
• Surgical Wound Dehiscence — all drugs for Surgical Wound Dehiscence →
• Bone Density — all drugs for Bone Density →

Sponsor

GBR Academy

Who can join

Adults 18 to 80, any sex, with Surgical Procedure, Unspecified or Soft Tissue Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The presence of alveolar ridge deficiencies is considered major limitation to achieve an implant-prosthetic restoration with high aesthetics and stability over time. Guided Bone Regeneration (GBR) can be considered an effective solution for bone augmentation. The most advanced technology of GBR is the customized titanium mesh, which is developed with a fully digital work flow system. The aim of this study is to evaluate complications and bone augmentation rates after GBR, based on customized meshes with or without collagen membranes.

After ethical committee approval, 30 patients with horizontal and/or vertical bone defects were enrolled and treated according to the study protocol. During reconstructive surgery (T0), patients were randomly divided into two study groups: 15 patients were treated by means of a custom-made mesh without collagen membrane (Group A - Control Group), while 15 patients were treated by means of a custom-made titanium mesh with a collagen membrane (Group B - Test Group). All sites were grafted with a mixture 50:50 of autogenous bone and xenograft and primary closures of surgical sites were obtained to ensure a submerged healing of the meshes. After 6 months (T1), re-entry surgery was completed to remove the meshes, evaluate the augmented volume and to place implants in the augmented sites. After 3 months (T2), soft tissue management was accomplished with implant exposure and a connective tissue graft, before prosthetic restoration (T3). Data collection included surgical and healing complications, planned bone volume (PBV) and reconstructed bone volume (RBV), pseudo-periosteum type, bone density, implant success, and crestal bone loss. A statistical analysis of recorded data was performed to investigate any statistically significant differences between the study group and statistical significance was set at a=0.05.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vertical and horizontal ridge augmentation using customized CAD/CAM titanium mesh with versus without resorbable membranes. A randomized clinical trial.
   Cucchi A, Vignudelli E, Franceschi D, Randellini E, et al · · 2021 · cited 59× · PMID 34551168 · DOI 10.1111/clr.13841
2. A 3D micro-CT assessment of composition and structure of bone tissue after vertical and horizontal alveolar ridge augmentation using CAD/CAM-customized titanium mesh.
   Cucchi A, Marchiori G, Sartori M, Fini M, et al · · 2024 · cited 5× · PMID 39106169 · DOI 10.1111/clr.14342