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ACTIVE NOT RECRUITING
NCT07646795
NA

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

Sponsor: Martina Stefanini

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-11-27

Completion Date

2027-07

Last Updated

2026-06-15

Healthy Volunteers

No

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).

Locations (1)

Periodontal Unit, Department of Biomedical and Neuromotor Sciences, UNiversity of Bologna

Bologna, BO, Italy