Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percent New Bone Formation
研究概览
简要总结
The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.
Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.
详细描述
This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.
Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
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 surgeon and the subject will not be blinded. The evaluation of the core histology will be done by a blinded investigator.
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
- •Non-restorable single rooted tooth in anterior or premolar region
- •Patient previously treatment planned for implant procedure and implant restoration.
- •> 10 mm from maxillary sinus or inferior alveolar canal (IAC)
- •Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
- •Non-smokers.
- •Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.
排除标准
- •Poor oral hygiene (plaque index>30%).
- •Systemic diseases that affect bone metabolism:
- •i. Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease
- •Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
- •i. Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus
- •History of radiation to the head and neck, and /or chemotherapy.
- •Current corticosteroid therapy.
- •History of IV Bisphosphonates therapy or >3 years of oral intake.
- •Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
- •Known allergy to research related materials.
- •Self-reported pregnancy or lactation
结局指标
主要结局
Percent New Bone Formation
时间窗: 4-6 months after ridge preservation surgery
Histomorphometric determination of % new bone formation
次要结局
- Bone Density(4-6 months after ridge preservation surgery)
研究者
Yong Hur
Assistant Professor
Tufts University