Biotivity A-C Membrane Socket Preservation Study

Conditions

• Alveolar Ridge Preservation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Amnion chorion membrane — DEVICE
  Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
• Collagen membrane — DEVICE
  Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..

Study Details

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.

Key Dates

Start date

Apr 1, 2026

Status verified

Jan 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Alveolar ridge preservation with amnion chorion membrane
  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.
• Active Comparator: Alveolar ridge preservation with collagen membrane
  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.

Primary Outcome Measure

Soft Tissue Wound Healing Score Using Wound Healing Indices [ Time Frame: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6]. ]

Central Contacts

• Hanae Saito, DDS MS CCRC
  410-706-3646
  [email protected]

Locations (1)

Find similar trials in Baltimore, MD

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