Biotivity A-C Membrane Socket Preservation Study

Phase 4Not Yet RecruitingNCT07091448

University of Maryland, Baltimore12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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].

Secondary Outcomes

Radiographic measurement of Mean Change at 4 Months Measured by CBCT

Vertical and volumetric changes in alveolar ridge dimensions will be assessed using cone-beam computed tomography (CBCT) taken at baseline (post-extraction) and 4 months after alveolar ridge preservation. Vertical bone height will be measured at the mid-buccal point from the cementoenamel junction (CEJ) to the alveolar crest. Volumetric bone change will be calculated at 1 mm, 3 mm, and 5 mm apical to the alveolar crest using cross-sectional slices and 3D analysis software (Geomagic Control X). Data will be reported as mean change (mm for height; mm³ for volume) and standard deviation per group.

Time frame: 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

Buccal soft tissue thickness will be evaluated using superimposed STL files obtained from intraoral digital scans. Scans will be collected at baseline, immediate post-surgery and 4 month post-surgery. Thickness will be measured at the mid-buccal point of the site, and changes will be reported as mean (mm) per group.

Time frame: 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]).

Biotivity A-C Membrane Socket Preservation Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts