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COMPLETED

NCT06059898

Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration

Sponsor: Botiss Medical AG

View on ClinicalTrials.gov

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 cavity. The membrane ensures sufficient stability of the bone augmentation material and provides a barrier to the soft tissue. This enables new bone to form in the defect space and for the subsequent placement of dental implants. In this clinical trial, the NOVAMag® membrane is compared with the Jason® collagen membrane, another medical device for supporting bone regeneration, with the aim of demonstrating the non-inferiority in terms of radiographically measured volumetric bone gain of the NOVAMag® membrane to the comparator membrane.

Official title: A Randomized Clinical Study Comparing the Bioresorbable Magnesium NOVAMag® Membrane With the Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2022-04-08

Completion Date

2025-09-30

Last Updated

2026-04-21

Healthy Volunteers

Conditions

Ridge Augmentation

Interventions

DEVICE

GBR surgery including membrane placement

After the application of local anesthesia, an incision of the mucosa will be performed and the flap will be elevated. The flap closure line should not be directly over the defect, but away from the defect site to prevent wound dehiscence. The bony defect will be thoroughly cleaned and, in some cases, activated by drilling small holes in the cortical bone to increase blood flow into the bone graft. Bone substitute will be inserted, the membrane will be adapted and fixed, and the flap will be sutured

PROCEDURE

Biopsy

After a healing period of 6 months, at the implantation site, a biopsy is taken from the site of dental implant insertion for further analysis of bone regeneration

Eligible are healthy patients that have the need for at least one dental implant. Specific inclusion criteria are: 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

Locations (5)

Medical University of Graz Department of Dental Medicine and Oral Health

Graz, Austria

University of Vienna, Department of Oral Surgery

Vienna, Austria

Copenhagen University Hospital, Department of Oral & Maxillofacial Surgery

Copenhagen, Denmark

Studio medico odontoiatrico Papi Stp Srl

Roma, Italy

Studio Tabanella