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Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study

NCT07646795 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-06-15

No results posted yet for this study

Summary

When a tooth is removed, the surrounding bone and gum tissue naturally shrink over time. This shrinkage can make it harder to place a dental implant later and may affect the appearance of the smile. To reduce bone loss after extraction, surgeons can fill the socket with a bone substitute material and cover it with a protective membrane.

This study tests a new type of membrane made from magnesium metal (NOVAMag®). Unlike standard resorbable membranes, the magnesium membrane is rigid enough to hold its shape and protect the bone graft even in severely damaged sockets - similar to non-resorbable membranes. Unlike non-resorbable membranes, however, it dissolves on its own within about 16 weeks, so no second surgery is needed to remove it. As it breaks down, it releases magnesium ions that may also help stimulate new bone formation.

This study will enroll 10 adult patients who need a tooth removed and plan to have a dental implant placed afterward. After extraction, the socket will be filled with a bovine bone substitute, covered with the magnesium membrane, and sealed with a collagen membrane on top. Patients will be followed for up to 19 months. At 6 months, a CT scan will be used to measure how much bone has been preserved. At the time of implant placement, a small bone sample will be analyzed in the laboratory to assess new bone formation. Patients will also complete questionnaires about pain and quality of life, and the healing of the surgical site will be monitored at each visit.

The goal is to find out whether this magnesium membrane can effectively preserve bone after tooth extraction, reduce the need for additional bone grafting before implant placement, and offer a less invasive option for patients.

Conditions

  • Bone Augmentation
  • Alveolar Ridge Augmentation

Interventions

DEVICE

NOVAMag®

Resorbable pure magnesium metal barrier membrane (NOVAMag®, Botiss Biomaterials, Berlin, Germany). Shaped and trimmed intraoperatively to fully cover the bony defect at the post-extraction site. Placed between the bone substitute and the overlying soft tissues to maintain space and support bone regeneration. Degrades completely within approximately 16 weeks without requiring surgical removal. Bovine-derived granular bone substitute (Cerabone plus, Botiss Biomaterials, Berlin, Germany). Used to fill the extraction socket up to the crestal bone border following thorough socket debridement and placement of the magnesium membrane. Porcine-derived acellular collagen matrix (Mucoderm®, Botiss Biomaterials, Berlin, Germany). Placed coronally to seal the socket and prevent exposure of the bone graft and magnesium membrane. Fixed to adjacent crestal soft tissues with cross-mattress sutures (6.0 PGA).

Sponsors & Collaborators

  • Martina Stefanini

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-27
Primary Completion
2026-09-30
Completion
2027-07-31

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 NCT07646795 on ClinicalTrials.gov