Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Zagreb
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
NOVAMag Membrane
DevicePlacement of a resorbable magnesium barrier membrane over the grafted extraction socket during alveolar socket preservation.
permamem Membrane
DevicePlacement 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/SurgeryAtraumatic 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Allogeneic Bone Graft With NOVAMag MembraneExperimental treatment 2 interventions
Group B: Allogeneic Bone Graft With permamem MembraneActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline before tooth extraction and 3 months after alveolar socket preservationSecondary 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.
Time frame
3 months after alveolar socket preservation, at implant placementOther outcomes
1
Percentage of Residual Bone Graft Material
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.
Time frame
3 months after alveolar socket preservation, at implant placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Zagreb
Lead sponsor
Botiss Biomaterials GmbH
Collaborator
Source ClinicalTrials.gov
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