MedTrace Logo

Non-resorbable Membranes Versus Titanium Meshes and Resorbable Membranes

NCT04332679 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-04-03

No results posted yet for this study

Summary

The objective of this study is to compare two surgical techniques for the treatment of the mandibular bone atrophies: Dense PTFE titanium-reinforced membranes (Group A) versus Titanium mesh covered with cross-linked collagen membranes (Group B).

Therefore, the main purposes are to compare test and control regarding (i) the percentage of post-operative complications (ii) the three-dimensional bone gain (iii) histological, histomorphometrical and microCT outcomes (iv) perImplant bone loss and soft tissue parameters.

Conditions

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

Interventions

DEVICE

Group A - control group

20 patients treated by means of a dense PTFE (d-PTFE) titanium-reinforced membrane (Cytoplast Ti-250XL; Osteogenics Biomedical) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

DEVICE

Group B - Test group

20 patients treated by means of Ti mesh (Trinon Titanium; Karlsruhe, Germany) and cross-linked collagen membrane (Osseoguard, Zimmer Biomet, Warsaw, IN, USA) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).

Sponsors & Collaborators

  • GBR Academy

    lead NETWORK

Principal Investigators

  • Giuseppe Corinaldesi · unibo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-01
Primary Completion
2016-09-01
Completion
2019-09-01

Countries

  • Italy

Study Locations

More Related Trials

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 NCT04332679 on ClinicalTrials.gov