Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean change in radiographic horizontal and vertical ridge dimensions
研究概览
简要总结
The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material.
The study aims to examine the following main questions:
- Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing
- Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated.
The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:
- Demographic information
- Clinical information from intraoral photographs
- Radiographic information from cone beam computed tomography and periapical radiographs.
详细描述
The study will compare clinical, radiographic (dental cone beam computed tomography) and histologic outcomes upon tooth extraction and alveolar ridge preservation (ARP) as well as clinical, radiographic and patient-reported outcomes upon implant placement and crown fabrication at the same site.
Both bone graft materials (FDBA and CEBX) are FDA approved and are widely available in the US market and are routinely used in everyday practices and within the university.
- FDBA is produced by Community Blood Center (Community Tissue Services, Ohio, USA) (FEI: 3008808182).
- CEBX is produced by Geistlich Pharma AG (Wolhusen, Switzerland) [501(k) #: K122894].
Both materials will be stored and utilized based on manufacturers' recommendations and as per of Standard of Care protocols within the university.
Participants and investigators will be unaware of the envelope content and each participant will be asked to randomly pick an envelope and immediately both the participant as well as the investigator will be informed about the envelope content and, therefore, the group allocation. Eventually, participants and investigators will be aware of the group allocation, except for the investigator who will conduct all the study measurements who will remain blinded.
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)
盲法说明
The outcome assessor will be blinded in regards to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients able to provide informed consent
- •patients of 18 years of age or older at time of consent and enrollment
- •patients in need of at least one anterior tooth extraction and seeking dental implant replacement
- •bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence </=5mm as determined radiographically through cone beam computed tomography (CBCT)
排除标准
- •current smokers or tobacco-product users (self-reported)
- •uncontrolled diabetes (HbA1c≥7 in the last 3 months)
- •pregnant and/or lactating females (self-reported)
- •patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update
- •patients with history of radiation of the head and neck
- •patients with allergy to collagen, bacitracin and/or polymyxin B
- •patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material
- •patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves
- •patients with untreated periodontitis
- •patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area
- •patients with central/lateral incisors or canines with buccal bone dehiscence >5mm
研究组 & 干预措施
FDBA arm
干预措施: FDBA (Device)
CEBX arm
干预措施: CEBX (Device)
结局指标
主要结局
Mean change in radiographic horizontal and vertical ridge dimensions
时间窗: baseline to 16 weeks after surgery
Linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes will be measured and compared between groups after 16 weeks of healing.
次要结局
- Mean change in alveolar ridge contour(baseline to 12 months after implant placement, approximately 70 weeks)
- Number of implants/participants with an implant placed on a prosthetically driven position(16 weeks)
- Mean percentage of residual bone graft particles(16 weeks)
- Mean percentage of new bone formation(16 weeks)
- Mean percentage of connective tissue(16 weeks)
- Mean probing depth(2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks))
- Mean percentage of implant surfaces with bleeding(2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks))
- Mean percentage of implant surfaces with plaque(2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks))
- Mean width of keratinized mucosa(2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks))
- Mean migration of peri-implant mucosal margin(2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks))
- Mean change peri-implant marginal bone level changes(16 weeks to 2 months after implant placement (approximately 8 weeks) and 16 weeks to 12 months after implant placement (approximately 54 weeks))
- Mean implant-crown esthetic score(12 months after implant placement, approximately 70 weeks)
- Mean patient satisfaction score(12 months after implant placement, approximately 70 weeks)
- Mean change in alveolar ridge contour(baseline to 4 weeks after surgery)
- Mean change in alveolar ridge contour(baseline to 2 months after implant placement, approximately 24 weeks)
研究者
Elli Kotsailidi
Assistant professor
University of Rochester