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NOT YET RECRUITING
NCT07091448
PHASE4

Biotivity A-C Membrane Socket Preservation Study

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective, Assessment of Alveolar Ridge Preservation Using Biotivity™ Amnion Chorion Membranein Atraumatic Extraction Socket

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-04-01

Completion Date

2028-10-31

Last Updated

2026-01-28

Healthy Volunteers

Yes

Interventions

DEVICE

Amnion chorion membrane

Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.

DEVICE

Collagen membrane

Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..

Locations (1)

University of Maryland School of Dentistry

Baltimore, Maryland, United States