A Randomized, Split Mouth Study of the Effects of Bone Graft Particle Size on Bone Vitality and Bone Volume Outcomes in Subjects Undergoing Sinus Augmentation for the Placement of Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Quality of Bone
研究概览
简要总结
To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.
详细描述
The proposed study is a Randomized, single-masked, split-mouth, single center study.
About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.
At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:
- Bone graft A: A mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (N=10)
- Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus.
At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good physical health
- •Capable of maintaining good oral hygiene
- •Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
- •Capable and willing to give informed consent
排除标准
- •The presence of underlying medical conditions that may pose an undue risk for sinus surgery
- •Patients with untreated oral infections
- •Pregnant and lactating females
- •Individuals who have the habit of smoking and/or tobacco chewing
- •Patients not willing to participate in the study
研究组 & 干预措施
Bone Graft A
Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft
干预措施: Puros allograft (Device)
Bone Graft B
Bone Graft B: 100% large particle cancellous allograft
干预措施: Puros allograft (Device)
结局指标
主要结局
Quality of Bone
时间窗: After surgery, 8 months, 1 year
Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent vital bone formation, percent of inflammatory tissue if any
次要结局
- Bone Volume Stability(After surgery, 8 months, 1 year)
研究者
Katerina Georgantza, DDS
Clinical Assistant Professor
NYU College of Dentistry