Status:
UNKNOWN
Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration
Lead Sponsor:
Botiss Medical AG
Collaborating Sponsors:
CONVIDIA clinical research GmbH
Botiss Biomaterials GmbH
Conditions:
Guided Bone Regeneration (GBR)
Ridge Augmentation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The NOVAMag® membrane is a medical device approved in the EU, and is a completely resorbable and biodegradable metal membrane. This medical device is used in the treatment of bone defects in the oral ...
Detailed Description
GBR is a well-established surgical procedure based on the use of tissue barriers to separate the void of hard tissue defects from overlying connective tissues, thus preventing the ingrowth of soft tis...
Eligibility Criteria
Inclusion
- 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
- The patient shall be at least 18 years of age, male or female and have passed cessation of growth
- 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.
- 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
- Systemic exclusion criteria
- 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)
- Acute infectious diseases
- Immunocompromised patients
- Serious disturbances of bone metabolism and/or serious bone diseases of endocrine etiology
- 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
- Previous or current use of antiresorptive medication (e.g. bisphosphonates)
- Previous oral / maxillofacial radiotherapy
- Heavy smoker (definition: \>10 cigarettes per day)
- Currently pregnant or breastfeeding women
- Health conditions, which do not permit the surgical treatment
- Local exclusion criteria
- Acute local inflammation or untreated periodontitis
- Insufficient oral hygiene
- Regenerative periodontal treatment necessary adjacent to the planned study site of interest
- Mucosal diseases or oral white or ulcerative lesions (e.g. lichen planus, leukoplakia)
- History of head and neck irradiation therapy
- Severe bruxism or clenching or other destructive habits
- Previous socket preservation, GBR or guided tissue regeneration (GTR) treatment at the implant site
- Infections in tissue and adjacent tissue of the planned implantation site
- Known hypersensitivity to any of the trace elements
- Edentulous cases
Key Trial Info
Start Date :
April 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2023
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06059898
Start Date
April 8 2022
End Date
November 1 2023
Last Update
September 29 2023
Active Locations (5)
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1
Medical University of Graz Department of Dental Medicine and Oral Health
Graz, Austria, 8010
2
University of Vienna, Department of Oral Surgery
Vienna, Austria, 1090
3
Copenhagen University Hospital, Department of Oral & Maxillofacial Surgery
Copenhagen, Denmark, 2100
4
Studio medico odontoiatrico Papi Stp Srl
Roma, Italy, 00176