Clinical Trial

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

Study acronym: NOVAMAG-2024
Active, Not Recruiting
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.
Trial Details
NCT Number NCT07646795
Lead Sponsor Martina Stefanini
Conditions Bone Augmentation, Alveolar Ridge Augmentation
Enrollment 10 participants
Start Date 2024-11-27
Primary Completion 2026-09 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-15