Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
brief summary
After a tooth is removed, the surrounding bone and gum tissue can shrink. Socket preservation places a bone graft in the extraction socket and covers it with a membrane to support healing before a dental implant is placed. 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 who need a tooth extraction and later implant placement will be randomly assigned to one of the two groups. The extraction and grafting procedures will be standardized. Follow-up examinations will take place 7 days, 21 days, and 3 months after socket preservation. The study will assess gum healing and postoperative complications. Cone beam computed tomography scans obtained before extraction and at 3 months will be used to evaluate changes in alveolar bone volume. A bone sample will be collected from the treated site during the planned implant placement at 3 months 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 and subsequent implant placement in the treated region. Participants will be classified as American Society of Anesthesiologists physical status 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 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 assessment will evaluate newly formed bone and residual graft material. Clinical, radiographic, and histological findings will be compared between groups.
The protocol states 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; no equivalence or non-inferiority margin is specified.
official title
Comparative Evaluation of Bone and Soft Tissue Healing Following Alveolar Socket Preservation Using Maxgraft Plus With NOVAMag and Permamem Membranes