Biotivity A-C Membrane Socket Preservation Study

University of Maryland Baltimore (UMB)

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Alveolar Ridge Preservation

Treatments: Device: Amnion chorion membrane; Device: Collagen membrane

Study type: Interventional

Funder types: Other

Identifiers

NCT07091448

HP-00114841

Details and patient eligibility

About

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.

Full description

This randomized, controlled, parallel-arm clinical study investigates the use of Biotivity™ A/C Plus Membrane, a bioactive human amnion chorion-derived barrier membrane, in alveolar ridge preservation (ARP) of Type I or II extraction sockets. Subjects will be randomized to receive either the investigational amnion chorion membrane or a conventional collagen membrane (CopiOs Extend) over cancellous allograft (Puros®) after flapless tooth extraction in the premolar or molar region (excluding third molars).

The study will evaluate:

Primary outcome: soft tissue wound healing over 5 months using standardized wound healing indices.

Secondary outcomes: hard and soft tissue dimensional changes using CBCT and intraoral scanning, histologic evaluation of new bone formation, and implant placement feasibility.

Subjects will be followed across nine visits, including baseline (screening), ARP surgery, post-operative evaluations at multiple time points, and re-entry for implant placement at 5 months. The final implant-supported restoration will be delivered after implant integration, with continued follow-up for histologic and radiographic outcomes.

This study aims to determine whether the amnion chorion membrane provides superior soft tissue healing and volumetric bone preservation compared to conventional membranes in ARP procedures, with the goal of improving clinical outcomes in implant dentistry.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

1. Provision of informed consent
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site

Exclusion criteria

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c > 8.0 within last six-month13,14
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
12. Pregnancy, as confirmed by a urine pregnancy test at screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

12 participants in 2 patient groups

Alveolar ridge preservation with amnion chorion membrane

Experimental group

Description:

The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called Biotivity™ A-C Plus.

Treatment:

Device: Amnion chorion membrane

Alveolar ridge preservation with collagen membrane

Active Comparator group

Description:

The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called CopiOs.

Treatment:

Device: Collagen membrane