Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes

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.

• NOVAMag Membrane (Device): Placement of a resorbable magnesium barrier membrane over the grafted extraction socket during alveolar socket preservation.
• permamem Membrane (Device): Placement of a non-resorbable polytetrafluoroethylene barrier membrane over the grafted extraction socket during alveolar socket preservation.
• Alveolar Socket Preservation With an Allogeneic Bone Graft (Procedure): 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.

Primary outcomes

• Change in Alveolar Bone Volume at the Treated Site [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.

Secondary outcomes

• Percentage of Newly Formed Bone [3 months after alveolar socket preservation, at implant placement]: 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.

Other outcomes

• Percentage of Residual Bone Graft Material [3 months after alveolar socket preservation, at implant placement]: Residual graft material will be quantified in the bone biopsy obtained at implant placement. The outcome will be the area of residual graft particles divided by the total analyzed tissue area, multiplied by 100, and expressed as a percentage.

Sex: All, ages: 25 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

• Igor Smojver, DMD;PhD, Study director, University of Zagreb