Ridge AugmentationNCT06059898
Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration
A study testing GBR surgery including membrane placement and Biopsy in people with Ridge Augmentation, run by Botiss Medical AG at 5 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ridge Augmentation
- What is being tested?
- GBR surgery including membrane placement and Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 8 Apr 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Austria2 sites
Medical University of Graz Department of Dental Medicine and Oral Health
Graz, 8010
University of Vienna, Department of Oral Surgery
Vienna, 1090
Italy2 sites
Studio medico odontoiatrico Papi Stp Srl
Roma, 00176
Studio Tabanella
Roma, 00198
Denmark1 site
Copenhagen University Hospital, Department of Oral & Maxillofacial Surgery
Copenhagen, 2100
About this study
Official title: A Randomized Clinical Study Comparing the Bioresorbable Magnesium NOVAMag® Membrane With the Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration
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.
Read the 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 tissue into the defect site resulting in improved bone regeneration. GBR is used both with and without different bone graft materials, such as allografts, xenografts and synthetic substitute materials, which have shown comparable results to those obtained with autologous bone in localized horizontal defects.
The barrier membranes used in GBR can be produced from animal (bovine, porcine), human (allogenic) and synthetic biomaterials. Due to their origin, composition and manufacturing process, each biomaterial performs differently in the human body, with their own associated advantages and disadvantages.
Non-resorbable membranes (primarily made from PTFE [polytetrafluoroethylene] and titanium] can offer mechanical reinforcement to protect the defect void, as well as maintain a continuous barrier function until they are removed. The main disadvantage of these membranes is the necessity of a second surgical procedure for their removal.
In response to this disadvantage, resorbable membranes have been developed with porcine collagen membranes considering the standard product for use in GBR. These collagen membranes produce excellent biocompatible results, but they lack mechanical stability, especially for use in larger augmentation sites. To address the aforementioned issues of both the resorbable and non-resorbable membranes, botiss biomaterials GmbH has developed the NOVAMag® membrane, which has recently received CE approval. The NOVAMag® membrane is a resorbable, biodegradable magnesium membrane. The material properties of the pure magnesium membrane culminate into a design that has a mechanical stability not provided by other resorbable membranes. Despite being resorbable, the membrane maintains a separation of the soft and hard tissues until the bony defect has been repaired (data on file at botiss). The ability of membranes to resist collapse into the defect void and maintain space for the ingrowth of new bone is viewed as an important aspect for producing a successful regenerative outcome. This is most easily achieved by using a strong material that can resist the external pressures of the overlying soft tissue and the forces experienced during function. The risk of collapse tends to be higher for resorbable membranes due to inferior mechanical properties. Mechanical testing performed by botiss have proven that the magnesium membrane is self-supporting and substantially stronger than other resorbable collagen membranes. Therefore, the risk of collapse into the defect void, as reported for collagen membranes, could potentially be prevented by using the NOVAMag® membrane.
The aim of this randomized clinical study is to compare a bioresorbable magnesium NOVAMag® membrane with the collagen Jason® membrane in patients requiring guided bone regeneration.
- Conditions
- Ridge Augmentation
- Being tested
- GBR surgery including membrane placement, Biopsy
- Keywords
- Peridontal bone defect, Guided Bone Regeneration (GBR), Ridge augmentation, Peridontal bone defect requiring GBR ridge augmentation, Guided Tissue Regeneration (GTR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR surgery including membrane placementDevice
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
BiopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| NOVAMag membrane | Experimental | GBR procedure / membrane placement Receives: Device: GBR surgery including membrane placement; Procedure: Biopsy |
| Jason membrane | Active comparator | GBR procedure / membrane placement Receives: Device: GBR surgery including membrane placement; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative difference in bone volume between the groups at the augmentation site after GBR measured radiographically
Mean volumetric increase in %
Measured: 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
After 6 months a biopsy is taken from the site of dental implant insertion for further analysis. Undecalcified thin ground sections will be prepared. The following variables will be determined:
- Bone volume per tissue volume in % (BV/TV)
- New bone volume per tissue volume in % (nBV/TV)
- Old bone volume per tissue volume in % (oBV/TV)
- Total graft volume per tissue volume in % (GV/TV)
Measured: T5: after a healing period of 6 months
Evaluation of between group differences for the presence of side effects
Presence or absence of side effects will be evaluated by the investigator during the scheduled follow-up appointments.
Side effects to be assessed are:
- Gas formation
- Prickly feeling at surgery site (dysesthesia)
- Redness/swelling
- Bleeding
- Wound dehiscence
- Infection
- Abscess/pus formation
Measured: 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
Pain will be self-assessed by the patients via a numerical rating scale (NRS) during the scheduled follow-up appointments. The scale has a measurement range of 0 to 10 (each inclusive). The higher the value, the more pain the patients experience.
Measured: 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
The following Safety Endpoints will be evaluated by group at each visit:
- Adverse events (AE) and Serious adverse events (SAEs)
- Device related adverse events (adverse device effects (ADE)
- Seriousness of device related adverse events (serious adverse device effect (SADE)
- Device deficiency (DD)
Measured: 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
By completing a survey regarding the handling of the NOVAMag® membrane and its accessories by the investigator the usability will be evaluated.
Measured: At the end of the visit T0 [= day 0 = directly after GBR surgery]
Radiographic outcome measure: Changes in horizontal bone dimensions over time in mm.
At T-1 and T4 a Cone Beam Computed Tomography (CBCT) is taken. CBCTs are compared and horizontal bone dimensions are measured at 2 mm, 4 mm, and 6 mm from the crest.
Measured: At T-1 (pre-treatment) and T4 (5 and a half months ± 2 weeks)
Radiographic outcome measure: Changes in vertical bone dimensions over time in mm.
At T-1 and T4 a Cone Beam Computed Tomography (CBCT) is taken. CBCTs are compared and vertical bone dimensions are measured in mm.
Measured: At T-1 (pre-treatment) and T4 (5 and a half months ± 2 weeks)
Radiographic outcome measure: Bone quality assessment
Bone quality assessment by evaluation of presence or absence of gas cavities by analysis of CBCT images after 6 months (only presence is reported from X-rays)
Measured: T4 (after 5 and a half months ± 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start8 Apr 2022
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botiss Medical AG
- Sponsor type
- University, hospital or other
- Collaborators
- CONVIDIA clinical research GmbH, Botiss Biomaterials GmbH
- Responsible party
- Sponsor
- Investigators
- Werner Zechner, Prof. DDr., Principal investigator, University of Vienna, Department of Oral Surgery, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059898
- Sponsor's protocol ID
- NM-MEM-01
- Status last verified
- Apr 2026
- First submitted
- 4 Sep 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Study Comparing the Bioresorbable Magnesium NOVAMag® Membrane With the Collagen Jason® Membrane in Patients Requiring Guided Bone Regeneration
- ClinicalTrials.gov ID
- NCT06059898
- Acronym / sponsor ID
- NM-MEM-01
- Conditions
- Ridge Augmentation
- Keywords
- Peridontal bone defect, Guided Bone Regeneration (GBR), Ridge augmentation, Peridontal bone defect requiring GBR ridge augmentation, Guided Tissue Regeneration (GTR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Botiss Medical AGUniversity, hospital or other
- Collaborators
- CONVIDIA clinical research GmbH, Botiss Biomaterials GmbH
- Study start
- 8 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 tissue into the defect site resulting in improved bone regeneration. GBR is used both with and without different bone graft materials, such as allografts, xenografts and synthetic substitute materials, which have shown comparable results to those obtained with autologous bone in localized horizontal defects.
The barrier membranes used in GBR can be produced from animal (bovine, porcine), human (allogenic) and synthetic biomaterials. Due to their origin, composition and manufacturing process, each biomaterial performs differently in the human body, with their own associated advantages and disadvantages.
Non-resorbable membranes (primarily made from PTFE [polytetrafluoroethylene] and titanium] can offer mechanical reinforcement to protect the defect void, as well as maintain a continuous barrier function until they are removed. The main disadvantage of these membranes is the necessity of a second surgical procedure for their removal.
In response to this disadvantage, resorbable membranes have been developed with porcine collagen membranes considering the standard product for use in GBR. These collagen membranes produce excellent biocompatible results, but they lack mechanical stability, especially for use in larger augmentation sites. To address the aforementioned issues of both the resorbable and non-resorbable membranes, botiss biomaterials GmbH has developed the NOVAMag® membrane, which has recently received CE approval. The NOVAMag® membrane is a resorbable, biodegradable magnesium membrane. The material properties of the pure magnesium membrane culminate into a design that has a mechanical stability not provided by other resorbable membranes. Despite being resorbable, the membrane maintains a separation of the soft and hard tissues until the bony defect has been repaired (data on file at botiss). The ability of membranes to resist collapse into the defect void and maintain space for the ingrowth of new bone is viewed as an important aspect for producing a successful regenerative outcome. This is most easily achieved by using a strong material that can resist the external pressures of the overlying soft tissue and the forces experienced during function. The risk of collapse tends to be higher for resorbable membranes due to inferior mechanical properties. Mechanical testing performed by botiss have proven that the magnesium membrane is self-supporting and substantially stronger than other resorbable collagen membranes. Therefore, the risk of collapse into the defect void, as reported for collagen membranes, could potentially be prevented by using the NOVAMag® membrane.
The aim of this randomized clinical study is to compare a bioresorbable magnesium NOVAMag® membrane with the collagen Jason® membrane in patients requiring guided bone regeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOVAMag membrane | Experimental | Device: GBR surgery including membrane placement, Procedure: BiopsyGBR procedure / membrane placement |
| Jason membrane | Active comparator | Device: GBR surgery including membrane placement, Procedure: BiopsyGBR procedure / membrane placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBR surgery including membrane placementAfter 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 | Device | Jason membrane, NOVAMag membrane |
| BiopsyAfter 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 | Procedure or surgery | Jason membrane, NOVAMag membrane |
Primary outcome
Relative difference in bone volume between the groups at the augmentation site after GBR measured radiographically
Time frame: Pre-treatment visit (T-1) to the clinical check up visit after five and a half months (T4)
Mean volumetric increase in %
8 secondary outcomes
Histomorphometric assessment of the differences in bone volume between the groups
Time frame: T5: after a healing period of 6 months
Evaluation of between group differences for the presence of side effects
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the end of the visit T0 [= day 0 = directly after GBR surgery]
Radiographic outcome measure: Changes in horizontal bone dimensions over time in mm.
Time frame: At T-1 (pre-treatment) and T4 (5 and a half months ± 2 weeks)
Radiographic outcome measure: Changes in vertical bone dimensions over time in mm.
Time frame: At T-1 (pre-treatment) and T4 (5 and a half months ± 2 weeks)
Radiographic outcome measure: Bone quality assessment
Time frame: T4 (after 5 and a half months ± 2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Ridge Augmentation
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Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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Evaluating the Barrier Function, Regenerative Capacity, and Soft Tissue Outcomes of Acellular Dermal Matrix
Acellular Dermal Matrix, Bone Grafting
Not yet recruiting
Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Zechner, Prof. DDr. principal investigator
University of Vienna, Department of Oral Surgery, Austria
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GBR surgery including membrane placement and Biopsy in people with Ridge Augmentation, run by Botiss Medical AG at 5 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Italy, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative difference in bone volume between the groups at the augmentation site after GBR measured radiographically (time frame: Pre-treatment visit (T-1) to the clinical check up visit after five and a half months (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.