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NCT07646795
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Conditions: Bone Augmentation, Alveolar Ridge Augmentation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Martina Stefanini
Location: Periodontal Unit, Department of Biomedical and Neuromotor Sciences, UNiversity of Bologna Bologna BO
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.
Eligibility Criteria
Inclusion Criteria:
* • Patients agreeing to participate in the study
* Age 18 years or older
* Periodontally healthy (including patients currently in supportive periodontal maintenance therapy) or patients with ongoing periodontal treatment
* Compromised tooth because of severe periodontitis or root fracture
* full mouth plaque score \< 20% and full-mouth bleeding score \< 20% at the time of alveolar bone reconstruction
Exclusion Criteria:
* • Heavy smokers (≥10 cigarettes/day)
* Patients with a history of malignancy, radiotherapy, or chemo-therapy for malignancy.
* Pregnant patients or nursing during the past 6 months.
* Patients taking medications or having treatments with an effect on mucosal healing in general (e.g.steroids, large doses of anti- inflammatory drugs)
* Uncontrolled medical conditions, presence of systemic diseases or consumption of medications known to alter bone metabolism
* allergic reactions to bovine bone substitute
* patients that do not comply with the oral hygiene maintenance program and follow-up visits
Source: ClinicalTrials.gov (NCT07646795). StuddyBuddy aggregates publicly available trial information.