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

NCT07646795 | Active Not Recruiting

• 1 other identifier: NOVAMAG-2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

magnesium; postoperative; pain,; quality of life; oral health; patient-reported outcome measures; wound healing; membrane; alveolar ridge augmentation; BONE AUGMENTATION

Outcome Measures

Primary Outcomes (1)

• Alveolar Bone Dimensional Changes in Height and Width

  Alveolar bone changes in height (ARH) and width (ARW) measured in mm via CBCT scans at baseline and 6 months after alveolar ridge reconstruction. ARH is measured from the midpoint of the line connecting buccal and lingual/palatal crestal bone to a fixed anatomical reference point. ARW is measured at 1, 3, and 5 mm apical to that midpoint.

  Baseline and 6 months after alveolar ridge reconstruction

Secondary Outcomes (4)

• Soft Tissue Volumetric Changes

  Baseline and 6 months after alveolar ridge reconstruction

• New Bone Formation

  6 months after alveolar ridge reconstruction (at implant placement)

• Patient-Reported Outcomes

  7 days, 14 days, 1 month, 3 months, and 6 months after surgery

• Adverse Device Reactions

  From surgery up to 6 months after alveolar ridge reconstruction

Study Arms (1)

ID PATIENT

EXPERIMENTAL

Single-arm intervention consisting of tooth extraction followed by alveolar ridge reconstruction using: (1) xenogenic bone substitute (bovine-derived, granules) to fill the extraction socket up to the crestal bone border; (2) a resorbable pure magnesium barrier membrane (NOVAMag®) shaped and trimmed to cover the bony defect; and (3) a porcine-derived collagen membrane (Mucoderm®) placed coronally to seal the socket, fixed with cross-mattress sutures (6.0 PGA). Postoperative antibiotic prophylaxis: Amoxicillin 1g orally twice daily for 6 days, starting the day before surgery.

Device: NOVAMag®

Interventions

NOVAMag® DEVICE

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).

Also known as: Cerabone plus, Mucoderm®

ID PATIENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Martina Stefanini: lead

Study Sites (1)

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

Bologna, BO, 40125, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: November 27, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 15, 2026

Record last verified: 2025-09

Locations

IT (1)