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Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration

NCT06059898 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-04-21

No results posted yet for this study

Summary

The NOVAMag® membrane is a medical device approved in the EU, and is a completely resorbable and biodegradable metal membrane. This medical device is used in the treatment of bone defects in the oral cavity. The membrane ensures sufficient stability of the bone augmentation material and provides a barrier to the soft tissue. This enables new bone to form in the defect space and for the subsequent placement of dental implants. In this clinical trial, the NOVAMag® membrane is compared with the Jason® collagen membrane, another medical device for supporting bone regeneration, with the aim of demonstrating the non-inferiority in terms of radiographically measured volumetric bone gain of the NOVAMag® membrane to the comparator membrane.

Conditions

  • Ridge Augmentation

Interventions

DEVICE

GBR surgery including membrane placement

After the application of local anesthesia, an incision of the mucosa will be performed and the flap will be elevated. The flap closure line should not be directly over the defect, but away from the defect site to prevent wound dehiscence. The bony defect will be thoroughly cleaned and, in some cases, activated by drilling small holes in the cortical bone to increase blood flow into the bone graft. Bone substitute will be inserted, the membrane will be adapted and fixed, and the flap will be sutured

PROCEDURE

Biopsy

After a healing period of 6 months, at the implantation site, a biopsy is taken from the site of dental implant insertion for further analysis of bone regeneration

Sponsors & Collaborators

  • CONVIDIA clinical research GmbH

    collaborator UNKNOWN

  • Botiss Biomaterials GmbH

    collaborator INDUSTRY

  • Botiss Medical AG

    lead OTHER

Principal Investigators

  • Werner Zechner, Prof. DDr. · University of Vienna, Department of Oral Surgery, Austria

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-08
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Austria
  • Denmark
  • 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 NCT06059898 on ClinicalTrials.gov