Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Percent Vital Bone Formation
研究概览
简要总结
The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM.
The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.
详细描述
This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement.
Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.
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 (Participant)
盲法说明
Only investigators will know which material was used for the sinus lift.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between age 18 and 89
- •Patients needing sinus augmentation to support implant placement in the posterior maxilla
- •Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report
- •Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.
排除标准
- •Patients who disclose that they will not be able to cooperate with the follow-up schedule.
- •Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
- •Pregnant women or women intending to become pregnant during study period
- •Smokers who smoke > 10 cigarettes per day
研究组 & 干预措施
DFDBA Fibers with DBBM
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
干预措施: DFDBA fibers (Device)
DFDBA Fibers with DBBM
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
干预措施: DBBM (Device)
DFDBA Particles with DBBM
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
干预措施: DFDBA particles (Device)
DFDBA Particles with DBBM
After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.
干预措施: DBBM (Device)
结局指标
主要结局
Percent Vital Bone Formation
时间窗: Baseline to 6 months
Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery.
次要结局
未报告次要终点
研究者
Angela Palaiologou-Gallis, DDS, MS
Professor and Program Director, Graduate Periodontics
The University of Texas Health Science Center at San Antonio