Randomized Controlled Trial of Wound Healing Following Tooth Extraction and Ridge Preservation Using Decalcified Freeze-dried Bone Allograft (DFDBA) Alone in Particulate Fiber Form and in Combination With Xenograft
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 2
- 主要终点
- Percentage Vital Bone Formation
研究概览
简要总结
The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
详细描述
The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.
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
Since the outcome of the study is the histologic healing, blinding of the surgeon is not necessary.
Blinding is performed only for histomorphometric measurements. The person doing histomorphometric analysis is blinded as to study group.
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
- •One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
- •A dental implant is indicated and treatment planned to replace the missing tooth
- •Have adequate restorative space for a dental implant-retained restoration
- •Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
- •Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
- •Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
- •Are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day
排除标准
- •Will not cooperate with the follow-up schedule.
- •Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- •Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).
- •Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- •Smokers who smoke >10 cigarettes per day
- •Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.
结局指标
主要结局
Percentage Vital Bone Formation
时间窗: Wound healing time ( approximately 18 to 20 weeks)
Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.
次要结局
- Percentage of Residual Graft Material(Wound healing time ( approximately 18 to 20 weeks))
- Percentage of Connective Tissue at Time of Implant(Baseline to 18-20 weeks)
- Change in Ridge Width (Clinical Measurement)(Baseline to 18-20 weeks)
- Change in Buccal Ridge Height (Clinical Measurement)(Baseline to 18-20 weeks)
- Change in Lingual Ridge Height (Clinical Measurement)(Baseline to 18-20 weeks)