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Reinforced PTFE Meshes Versus Customized Titanium Meshes

NCT04257097 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-03-14

No results posted yet for this study

Summary

The objective of this study is to compare two surgical techniques for the treatment of the maxillary and mandibular bone atrophies.. Therefore, the main purpose is to compare the (i) the percentage of post-operative complications (ii) the three-dimensional bone gain with customized titanium meshes (test group - the medical device is digitally designed and made with customized laser sintering modality, customized to the defect of each patient) and with titanium-reinforced PTFE mesh (control group - the medical device is cut, shaped, and manually modelled to the patient's defect by the operator himself.

Conditions

  • Surgical Procedure, Unspecified
  • Soft Tissue Infections
  • Surgical Wound Dehiscence
  • Bone Density
  • Bone Loss
  • Dental Implant Failed

Interventions

DEVICE

RPM - Osteogenics Lubbock Texas USA

25 patients will undergo bone regeneration with a reinforced PTFE mesh, manually shaped and modelled by the operator during surgery (traditional technique), covered with collagen membranes of medium-rapid resorption

DEVICE

Yxoss CBR - Reoss Filderstadt Germany

25 patients undergo bone regeneration with a custom-made titanium mesh, digitally designed by an operator before the surgery (digital technique), covered by collagen membranes with medium-rapid resorption

Sponsors & Collaborators

  • GBR Academy

    lead NETWORK

Principal Investigators

  • Giuseppe Corinaldesi, MD,DDS,MS · School of dentistry - University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-01
Primary Completion
2022-11-01
Completion
2025-03-01

Countries

  • Italy

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 NCT04257097 on ClinicalTrials.gov