Biotivity A-C Membrane Socket Preservation Study

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

Qualifiers

Provision of informed consent

At least 18 years old

In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant

Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan

Disqualifiers

Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis

Previous interventions performed involving soft and/or bone grafting in the study site

Active caries

Uncontrolled periodontal disease present

Trial design

Treatments tested in this trial

  • Amnion chorion membrane
  • Collagen membrane

Treatment groups

12 Participants
are divided into 2 treatment groups