Biotivity A-C Membrane Socket Preservation Study

NCT07091448 | Not Yet Recruiting Phase 4 DMC FDA Device

• 1 other identifier: HP-00114841
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Soft Tissue Wound Healing Score Using Wound Healing Indices

  Wound healing will be assessed during post-surgery follow-up visits using the Early Wound Healing Index (Wachtel et al., 2003), which classifies flap closure into five categories (1 = complete closure, no fibrin; 5 = necrosis), and Wound Healing Index (WHI) described by Huang (2025 ) with three categories (1 = uneventful healing with no gingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.) Scores will be assigned by a blinded examiner. Data will be reported as the number of participants per score category and the median EHI score per treatment group.

  Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6].

Secondary Outcomes (2)

• Radiographic measurement of Mean Change at 4 Months Measured by CBCT

  Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).

• Soft Tissue Change from Baseline to 4 Months Using Intraoral Scans

  Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).

Study Arms (2)

Alveolar ridge preservation with amnion chorion membrane

EXPERIMENTAL

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.

Device: Amnion chorion membrane

Alveolar ridge preservation with collagen membrane

ACTIVE COMPARATOR

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.

Device: Collagen membrane

Interventions

Amnion chorion membrane DEVICE

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

Alveolar ridge preservation with amnion chorion membrane

Collagen membrane DEVICE

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

Alveolar ridge preservation with collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• At least one retained natural tooth adjacent to the study site

You may not qualify if:

• 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
• Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
• History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
• Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
• Self-reported use of smokeless tobacco or e-cigarette
• Self-reported history of current alcohol or drug abuse
• 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
• Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
• Pregnancy, as confirmed by a urine pregnancy test at screening.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland School of Dentistry

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Hanae Saito, DDS MS CCRC

  University of Maryland School of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanae Saito, DDS MS CCRC

CONTACT

410-706-3646; hsaito@umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 29, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)