Prospective, Assessment of Alveolar Ridge Preservation Using Biotivity™ Amnion Chorion Membranein Atraumatic Extraction Socket
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Soft Tissue Wound Healing Score Using Wound Healing Indices
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Amnion chorion membrane (Device)
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.
干预措施: Collagen membrane (Device)
结局指标
主要结局
Soft Tissue Wound Healing Score Using Wound Healing Indices
时间窗: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6].
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.
次要结局
- 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]).)