Active — Not RecruitingNot Applicable

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

Italy10 participantsStarted 2024-11-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Alveolar Bone Dimensional Changes in Height and Width

Timeframe: Baseline and 6 months after alveolar ridge reconstruction

Trial details

NCT IDNCT07646795

SponsorMartina Stefanini

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

View on ClinicalTrials.gov More Bone Augmentation trials