Comparing two types of membranes for bone regeneration in dental procedures
A Randomized Clinical Study Comparing the Bioresorbable Magnesium NOVAMag® Membrane With the Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration
NA · Botiss Medical AG · NCT06059898
This study is testing whether a new biodegradable metal membrane can help people getting dental implants grow bone just as well as a traditional collagen membrane.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Botiss Medical AG (other) |
| Locations | 5 sites (Graz and 4 other locations) |
| Trial ID | NCT06059898 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the NOVAMag® membrane, a biodegradable metal membrane, against the Jason® collagen membrane in patients undergoing guided bone regeneration (GBR) for dental implants. The study aims to demonstrate that the NOVAMag® membrane is non-inferior to the collagen membrane in terms of bone volume gain as measured radiographically. GBR is a surgical technique that uses barrier membranes to promote bone healing and prevent soft tissue ingrowth, and this trial will assess the performance of these two different membrane types in achieving successful bone regeneration. Participants will undergo GBR surgery with the placement of the assigned membrane and subsequent analysis of bone healing.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old requiring multiple dental implants and having a healed site that necessitates GBR.
Not a fit: Patients with major systemic diseases or those who have not healed sufficiently from previous dental extractions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and reliable option for bone regeneration in dental implant procedures.
How similar studies have performed: Other studies have shown promising results with similar GBR techniques, but the specific use of the NOVAMag® membrane is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Obtained informed consent from the patient, patients voluntarily signing the informed consent form before study related actions including patient's acceptance of the scheduled program of clinical and radiographic analysis 2. The patient shall be at least 18 years of age, male or female and have passed cessation of growth 3. Patients asking for more than one dental implant and presenting one site with a healed site (class h1i, h2i; h3i, v1i, c1i, h1e, h2e, h3e, Cologne Classification of Alveolar Ridge Defects (CCARD) requiring a GBR procedure prior to implant placement. 4. The teeth at the implant site must have been extracted or lost at least 8 weeks before the date of bone augmentation (volumetrically healed site) Exclusion Criteria: Systemic exclusion criteria 1. Major systemic diseases (e.g. recent myocardial infarction, cerebrovascular accident or valvular prosthesis surgery, a poorly stabilized diabetes mellitus, severe hypertension, severe peripheral artery occlusive disease, malignancies, autoimmune diseases, or kidney diseases, untreated or uncontrolled periodontal disease, uncontrolled drug or alcohol abuse, uncontrolled psychiatric disorders) 2. Acute infectious diseases 3. Immunocompromised patients 4. Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology 5. Due to judgement of the principal investigator: Medical conditions requiring prolonged use of steroids and/or on-going treatment with gluco- and mineralocorticoids and with agents affecting calcium metabolism (e.g. calcitonin), and/or anti-coagulative therapy 6. Previous or current use of antiresorptive medication (e.g. bisphosphonates) 7. Previous oral / maxillofacial radiotherapy 8. Heavy smoker (definition: \>10 cigarettes per day) 9. Currently pregnant or breastfeeding women 10. Health conditions, which do not permit the surgical treatment Local exclusion criteria 1. Acute local inflammation or untreated periodontitis 2. Insufficient oral hygiene 3. Regenerative periodontal treatment necessary adjacent to the planned study site of interest 4. Mucosal diseases or oral white or ulcerative lesions (e.g. lichen planus, leukoplakia) 5. History of head and neck irradiation therapy 6. Severe bruxism or clenching or other destructive habits 7. Previous socket preservation, GBR or guided tissue regeneration (GTR) treatment at the implant site 8. Infections in tissue and adjacent tissue of the planned implantation site 9. Known hypersensitivity to any of the trace elements 10. Edentulous cases
Where this trial is running
Graz and 4 other locations
- Medical University of Graz Department of Dental Medicine and Oral Health — Graz, Austria (RECRUITING)
- University of Vienna, Department of Oral Surgery — Vienna, Austria (RECRUITING)
- Copenhagen University Hospital, Department of Oral & Maxillofacial Surgery — Copenhagen, Denmark (RECRUITING)
- Studio medico odontoiatrico Papi Stp Srl — Roma, Italy (RECRUITING)
- Studio Tabanella — Roma, Italy (RECRUITING)
Study contacts
- Principal investigator: Werner Zechner, Prof. DDr. — University of Vienna, Department of Oral Surgery, Austria
- Study coordinator: Stefan Gesing, Dr.
- Email: Stefan.Gesing@Convidia.de
- Phone: +492512140131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Guided Bone Regeneration, Ridge Augmentation, Periodontal Bone Defect