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NCT07856693
Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
Conditions: Alveolar Bone Loss, Tooth Loss / Rehabilitation, Alveolar Bone Grafting, Socket Preservation
Sex: All
Ages: 25 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: University of Zagreb
Location: School of Dental Medicine Zagreb City of Zagreb
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.
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
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.
Source: ClinicalTrials.gov (NCT07856693). StuddyBuddy aggregates publicly available trial information.