Alveolar Bone LossNCT07856693
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
A study testing NOVAMag Membrane, permamem Membrane and Alveolar Socket Preservation With an Allogeneic Bone Graft in people with Alveolar Bone Loss and Tooth Loss / Rehabilitation, run by University of Zagreb at 1 site in Croatia.
Trial summary
After tooth extraction, the surrounding bone and soft tissue may undergo dimensional reduction. Socket preservation involves placement of a bone graft into the extraction socket and coverage with a membrane to support healing before dental implant placement. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss, Tooth Loss / Rehabilitation, Alveolar Bone Grafting
- What is being tested?
- NOVAMag Membrane, permamem Membrane and Alveolar Socket Preservation With an Allogeneic Bone Graft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Nov 2026to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults meeting the study's confirmed minimum age criterion.
- A tooth in the maxilla or mandible indicated for extraction.
- Planned dental implant placement in the treated region.
- American Society of Anesthesiologists physical status I or II.
- Written informed consent.
- Eligible extraction indications include periapical inflammatory lesions, retained roots, advanced periodontal destruction, tooth fractures, and teeth that cannot be restored or treated endodontically.
Who cannot join
- Uncontrolled chronic disease that may interfere with bone or soft tissue healing, including uncontrolled diabetes mellitus.
- Immune disorders or osteoporosis that may interfere with bone or soft tissue healing.
- Use of medications that affect bone metabolism.
- American Society of Anesthesiologists physical status III or higher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marko Vuletić, DMD;PhD contact
Croatia1 site
School of Dental Medicine
Zagreb, City of Zagreb, 10000
Marko Vuletić, PhD, +38514802119, mvuletic@sfzg.hr
Igor Smojver, PhD, ismojver@sfzg.hr
About this study
Official title: Comparative Evaluation of Bone and Soft Tissue Healing Following Alveolar Socket Preservation Using Maxgraft Plus With NOVAMag and Permamem Membranes
After tooth extraction, the surrounding bone and soft tissue may undergo dimensional reduction. Socket preservation involves placement of a bone graft into the extraction socket and coverage with a membrane to support healing before dental implant placement.
This study will compare two membranes used with the same allogeneic bone graft. One group will receive a resorbable magnesium membrane (NOVAMag), and the other group will receive a non-resorbable polytetrafluoroethylene membrane (permamem). Participants requiring tooth extraction followed by implant placement will be randomly assigned to one of the two groups.
Read more
Extraction and grafting procedures will be standardized. Follow-up examinations will take place 7 days, 21 days, and 3 months after socket preservation. Soft tissue healing and postoperative complications will be assessed. Cone-beam computed tomography (CBCT) scans obtained before extraction and at 3 months will be used to evaluate changes in alveolar bone volume. During planned implant placement at 3 months, a bone sample will be collected from the treated site for microscopic examination.
The study aims to compare bone and soft tissue healing between the two membrane groups.
Read the detailed description
Tooth extraction is followed by changes in alveolar bone and soft tissue dimensions that may affect subsequent implant treatment. This prospective, randomized, controlled clinical study will compare healing after alveolar socket preservation using an allogeneic bone graft covered by either a resorbable magnesium membrane (NOVAMag) or a non-resorbable polytetrafluoroethylene membrane (permamem).
The study will be conducted at the Department of Oral Surgery, School of Dental Medicine, University of Zagreb. Eligible participants will require tooth extraction in the maxilla or mandible followed by implant placement in the treated region. Eligible participants will have an American Society of Anesthesiologists physical status classification of I or II and will provide written informed consent.
Following atraumatic extraction under local anesthesia, granulation tissue will be removed from the socket. The socket will be irrigated with sterile saline and filled with the same allogeneic bone graft in both groups. Participants will be randomly allocated to either the NOVAMag group or the permamem group. Membranes will be adapted to the socket dimensions and placed according to the applicable surgical protocol. Anesthesia, extraction technique, and suturing will be standardized between groups.
Clinical examinations will be performed at 7 days, 21 days, and 3 months after surgery to assess soft tissue healing and postoperative complications. CBCT imaging will be obtained before extraction and at 3 months, before implant placement, to assess changes in alveolar bone volume.
At implant placement, approximately 3 months after socket preservation, a bone sample will be collected from the treated site. Histological and histomorphometric assessments will evaluate newly formed bone and residual graft material. Clinical, radiographic, and histological findings will be compared between groups.
The protocol specifies a null hypothesis of no difference in bone and soft tissue healing between the membrane groups. The planned comparison is not an equivalence or non-inferiority trial, and no equivalence or non-inferiority margin is specified.
- Conditions
- Alveolar Bone Loss, Tooth Loss / Rehabilitation, Alveolar Bone Grafting, Socket Preservation
- Being tested
- NOVAMag Membrane, permamem Membrane, Alveolar Socket Preservation With an Allogeneic Bone Graft
- Keywords
- alveolar socket preservation, NOVAMag, permamem, Allogeneic bone graft, Histomorphometry
- Medical subject headings
- Alveolar Bone Loss, Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVAMag MembraneDevice
Placement of a resorbable magnesium barrier membrane over the grafted extraction socket during alveolar socket preservation.
permamem MembraneDevice
Placement of a non-resorbable polytetrafluoroethylene barrier membrane over the grafted extraction socket during alveolar socket preservation.
Alveolar Socket Preservation With an Allogeneic Bone GraftProcedure or surgery
Atraumatic tooth extraction, socket debridement, and saline irrigation, followed by placement of an allogeneic bone graft. The grafted socket will be covered with the membrane assigned to the participant's treatment group.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Bone Graft With NOVAMag Membrane | Experimental | Following atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with an allogeneic bone graft. The augmented socket will be covered with a resorbable magnesium membrane (NOVAMag). The remaining surgical procedures and follow-up schedule will be standardized between groups. Receives: Device: NOVAMag Membrane; Procedure: Alveolar Socket Preservation With an Allogeneic Bone Graft |
| Allogeneic Bone Graft With permamem Membrane | Active comparator | Following atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with the same allogeneic bone graft used in the experimental group. The augmented socket will be covered with a non-resorbable polytetrafluoroethylene membrane (permamem). The remaining surgical procedures and follow-up schedule will be standardized between groups. Receives: Device: permamem Membrane; Procedure: Alveolar Socket Preservation With an Allogeneic Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alveolar Bone Volume at the Treated Site
Alveolar bone volume will be measured on CBCT scans obtained before extraction and 3 months after socket preservation. Change will be calculated as the 3-month volume minus the baseline volume and reported in cubic millimeters. Measurements will use the same anatomically defined region of interest at both time points after image registration. Negative values indicate loss of measured bone volume.
Measured: Baseline before tooth extraction and 3 months after alveolar socket preservation
Secondary outcomes (1)
Percentage of Newly Formed Bone
Newly formed bone will be quantified by histomorphometric examination of a bone biopsy obtained from the treated site at implant placement. The outcome will be the area of newly formed bone divided by the total analyzed tissue area, multiplied by 100, and expressed as a percentage.
Measured: 3 months after alveolar socket preservation, at implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies 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
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Botiss Biomaterials GmbH
- Responsible party
- Principal investigator, Igor Smojver, University of Zagreb
- Investigators
- Igor Smojver, DMD;PhD, Study director, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856693
- Sponsor's protocol ID
- zvone1234
- Status last verified
- Sep 2026
- First submitted
- 28 Sep 2026
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Bone and Soft Tissue Healing Following Alveolar Socket Preservation Using Maxgraft Plus With NOVAMag and Permamem Membranes
- ClinicalTrials.gov ID
- NCT07856693
- Acronym / sponsor ID
- zvone1234
- Conditions
- Alveolar Bone Loss, Tooth Loss / Rehabilitation, Alveolar Bone Grafting, Socket Preservation
- Keywords
- alveolar socket preservation, NOVAMag, permamem, Allogeneic bone graft, Histomorphometry
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Collaborators
- Botiss Biomaterials GmbH
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 2 Oct 2026 (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.
After tooth extraction, the surrounding bone and soft tissue may undergo dimensional reduction. Socket preservation involves placement of a bone graft into the extraction socket and coverage with a membrane to support healing before dental implant placement.
This study will compare two membranes used with the same allogeneic bone graft. One group will receive a resorbable magnesium membrane (NOVAMag), and the other group will receive a non-resorbable polytetrafluoroethylene membrane (permamem). Participants requiring tooth extraction followed by implant placement will be randomly assigned to one of the two groups.
Extraction and grafting procedures will be standardized. Follow-up examinations will take place 7 days, 21 days, and 3 months after socket preservation. Soft tissue healing and postoperative complications will be assessed. Cone-beam computed tomography (CBCT) scans obtained before extraction and at 3 months will be used to evaluate changes in alveolar bone volume. During planned implant placement at 3 months, a bone sample will be collected from the treated site for microscopic examination.
The study aims to compare bone and soft tissue healing between the two membrane groups.
Detailed description
Tooth extraction is followed by changes in alveolar bone and soft tissue dimensions that may affect subsequent implant treatment. This prospective, randomized, controlled clinical study will compare healing after alveolar socket preservation using an allogeneic bone graft covered by either a resorbable magnesium membrane (NOVAMag) or a non-resorbable polytetrafluoroethylene membrane (permamem).
The study will be conducted at the Department of Oral Surgery, School of Dental Medicine, University of Zagreb. Eligible participants will require tooth extraction in the maxilla or mandible followed by implant placement in the treated region. Eligible participants will have an American Society of Anesthesiologists physical status classification of I or II and will provide written informed consent.
Following atraumatic extraction under local anesthesia, granulation tissue will be removed from the socket. The socket will be irrigated with sterile saline and filled with the same allogeneic bone graft in both groups. Participants will be randomly allocated to either the NOVAMag group or the permamem group. Membranes will be adapted to the socket dimensions and placed according to the applicable surgical protocol. Anesthesia, extraction technique, and suturing will be standardized between groups.
Clinical examinations will be performed at 7 days, 21 days, and 3 months after surgery to assess soft tissue healing and postoperative complications. CBCT imaging will be obtained before extraction and at 3 months, before implant placement, to assess changes in alveolar bone volume.
At implant placement, approximately 3 months after socket preservation, a bone sample will be collected from the treated site. Histological and histomorphometric assessments will evaluate newly formed bone and residual graft material. Clinical, radiographic, and histological findings will be compared between groups.
The protocol specifies a null hypothesis of no difference in bone and soft tissue healing between the membrane groups. The planned comparison is not an equivalence or non-inferiority trial, and no equivalence or non-inferiority margin is specified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Bone Graft With NOVAMag Membrane | Experimental | Device: NOVAMag Membrane, Procedure: Alveolar Socket Preservation With an Allogeneic Bone GraftFollowing atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with an allogeneic bone graft. The augmented socket will be covered with a resorbable magnesium membrane (NOVAMag). The remaining surgical procedures and follow-up schedule will be standardized between groups. |
| Allogeneic Bone Graft With permamem Membrane | Active comparator | Device: permamem Membrane, Procedure: Alveolar Socket Preservation With an Allogeneic Bone GraftFollowing atraumatic tooth extraction, the socket will be debrided, irrigated with sterile saline, and filled with the same allogeneic bone graft used in the experimental group. The augmented socket will be covered with a non-resorbable polytetrafluoroethylene membrane (permamem). The remaining surgical procedures and follow-up schedule will be standardized between groups. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults meeting the study's confirmed minimum age criterion.
- A tooth in the maxilla or mandible indicated for extraction.
- Planned dental implant placement in the treated region.
- American Society of Anesthesiologists physical status I or II.
- Written informed consent.
Key exclusion criteria (4 listed)
- Uncontrolled chronic disease that may interfere with bone or soft tissue healing, including uncontrolled diabetes mellitus.
- Immune disorders or osteoporosis that may interfere with bone or soft tissue healing.
- Use of medications that affect bone metabolism.
- American Society of Anesthesiologists physical status III or higher.
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 |
|---|---|---|
| NOVAMag MembranePlacement of a resorbable magnesium barrier membrane over the grafted extraction socket during alveolar socket preservation. | Device | Allogeneic Bone Graft With NOVAMag Membrane |
| permamem MembranePlacement of a non-resorbable polytetrafluoroethylene barrier membrane over the grafted extraction socket during alveolar socket preservation. | Device | Allogeneic Bone Graft With permamem Membrane |
| Alveolar Socket Preservation With an Allogeneic Bone GraftAtraumatic tooth extraction, socket debridement, and saline irrigation, followed by placement of an allogeneic bone graft. The grafted socket will be covered with the membrane assigned to the participant's treatment group. | Procedure or surgery | Allogeneic Bone Graft With NOVAMag Membrane, Allogeneic Bone Graft With permamem Membrane |
Primary outcome
Change in Alveolar Bone Volume at the Treated Site
Time frame: Baseline before tooth extraction and 3 months after alveolar socket preservation
Alveolar bone volume will be measured on CBCT scans obtained before extraction and 3 months after socket preservation. Change will be calculated as the 3-month volume minus the baseline volume and reported in cubic millimeters. Measurements will use the same anatomically defined region of interest at both time points after image registration. Negative values indicate loss of measured bone volume.
1 secondary outcome
Percentage of Newly Formed Bone
Time frame: 3 months after alveolar socket preservation, at implant placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Marko Vuletić, DMD;PhD contact
Igor Smojver, DMD;PhD study director
University of Zagreb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOVAMag Membrane, permamem Membrane and Alveolar Socket Preservation With an Allogeneic Bone Graft in people with Alveolar Bone Loss and Tooth Loss / Rehabilitation, run by University of Zagreb at 1 site in Croatia.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zvonimir Živković, DMD (+38514802119, zvonimirzivkovic94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alveolar Bone Volume at the Treated Site (time frame: Baseline before tooth extraction and 3 months after alveolar socket preservation). 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 7 Oct 2026.