Recruiting

Biotivity™ A/C Plus Membrane

Sponsor:

University of Maryland, Baltimore

Code:

NCT07091448

Conditions

Alveolar Ridge Preservation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Amnion chorion membrane

Collagen membrane

Study Details

Brief 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.

Conditions

Alveolar Ridge Preservation

Study ID

NCT07091448

Start date

Sep 1, 2026

Status verified date

Oct, 2026

Completion date

Oct 31, 2028

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Amnion chorion membrane

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

Collagen membrane

Alveolar ridge preservation of a single extraction socket site with a barrier membrane 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 and Locations

Central contacts

Hanae Saito, DDS MS CCRC

410-706-3646hsaito@umaryland.edu

Locations

University of Maryland School of Dentistry

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Hanae Saito, DDS MS CCRC

410-706-3646hsaito@umaryland.edu

Principal Investigator:

Hanae Saito, DDS MS CCRC

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.