Comparing two types of membranes for bone regeneration in dental procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.