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

NCT06059898 | Completed

• 1 other identifier: NM-MEM-01
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 5

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 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.

Conditions

Ridge Augmentation

Keywords

Peridontal bone defect; Guided Bone Regeneration (GBR); Ridge augmentation; Peridontal bone defect requiring GBR ridge augmentation; Guided Tissue Regeneration (GTR)

Outcome Measures

Primary Outcomes (1)

• Relative difference in bone volume between the groups at the augmentation site after GBR measured radiographically

  Mean volumetric increase in %

  Pre-treatment visit (T-1) to the clinical check up visit after five and a half months (T4)

Secondary Outcomes (8)

• Histomorphometric assessment of the differences in bone volume between the groups

  T5: after a healing period of 6 months

• Evaluation of between group differences for the presence of side effects

  At each follow-up visit: T1 (after 7-10 days), T2 (after 14 ± 3 days), T3 (after 1 month ± 4 days) and T5 (after 6 months ± 2 weeks)

• Evaluation of between group differences for pain

  At each follow-up visit: T1 (after 7-10 days), T2 (after 14 ± 3 days), T3 (after 1 month ± 4 days) and T5 (after 6 months ± 2 weeks)

• Safety outcome measures

  At T-1 (pre-treatment), T0 (= day 0 = day of surgery), T1 (after 7-10 days), T2 (after 14 ± 3 days), T3 (after 1 month ± 4 days), T5 (after 6 months ± 2 weeks), T6 (7-10 days after T5)

• Usability of the NOVAMag® membrane and its accessory products

  At the end of the visit T0 [= day 0 = directly after GBR surgery]

Study Arms (2)

NOVAMag membrane

EXPERIMENTAL

GBR procedure / membrane placement

Device: GBR surgery including membrane placement; Procedure: Biopsy

Jason membrane

ACTIVE COMPARATOR

GBR procedure / membrane placement

Device: GBR surgery including membrane placement; Procedure: Biopsy

Interventions

GBR surgery including membrane placement DEVICE

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

Jason membrane; NOVAMag membrane

Biopsy PROCEDURE

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

Jason membrane; NOVAMag membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Botiss Medical AG: lead
• CONVIDIA clinical research GmbH: collaborator
• Botiss Biomaterials GmbH: collaborator

Study Sites (5)

Medical University of Graz Department of Dental Medicine and Oral Health

Graz, 8010, Austria

Location

University of Vienna, Department of Oral Surgery

Vienna, 1090, Austria

Location

Copenhagen University Hospital, Department of Oral & Maxillofacial Surgery

Copenhagen, 2100, Denmark

Location

Studio medico odontoiatrico Papi Stp Srl

Roma, 00176, Italy

Location

Studio Tabanella

Roma, 00198, Italy

Location

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Werner Zechner, Prof. DDr.

  University of Vienna, Department of Oral Surgery, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 29, 2023
• Study Start: April 8, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); IT (2); AU (2)