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Biotivity A-C Membrane Socket Preservation Study

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Notable Recruitment opened Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Notable Start date: Apr 1, 2026 to Aug 1, 2026v4
  3. Notable Primary completion date: Oct 31, 2026 to Oct 31, 2027
    • Start date: Nov 1, 2025 to Apr 1, 2026
    • Study completion date: Oct 31, 2027 to Oct 31, 2028
    • Eligibility criteria expanded, about 8 words
    v3
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement. Throughout the approximately 6-month study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material and barrier placement, and dental implant placement. Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.
Trial Details
NCT Number NCT07091448
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Alveolar Ridge Preservation
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov