Human Alveolar Bone Augmentation: Comparison 3-D CAD-CAM Ti-mesh Frame With a Conventional Ti-Mesh Frame Fabricated at Time of Surgery
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Surgical exposure time for recipient site
研究概览
简要总结
This research compares a chairside Titanium Mesh frame fabrication used during bone grafting procedures with the use of a computer-aided design/computer-assisted manufacture (CAD-CAM) Titanium Mesh frame. In addition, a novel method of measuring soft tissue thickness will be tested using an Optical scanner at various times during the sequence of surgeries.
The device used for shaping is a very thin, perforated titanium metal sheet with numerous small perforations (referred to as Micromesh). The construction of this device is usually accomplished chairside at the time of the surgery with custom cutting and shaping done using cues from the geometry of the surgical defect. An alternative approach will be tested where the mesh is pre-designed using digital information provided by a special xray and an optical scan device which takes a digital impression of the tooth and soft tissue surface. A digitally designed frame can then be printed using CAD-CAM software prior to surgery. This should reduce surgical time.
A randomized control trial of 30 patients needing 3-D bone augmentation will be conducted comparing chairside fabrication of Ti-MESH or TEST- CAD-CAM designed and preprinted Ti-MESH to investigate these objectives:
- Compare the operative times required for placement and removal of two different Ti-MESH frame fabrications
- Compare post-op wound healing -Ti MESH exposure rates, bone production (volume, contour, and quality) and soft tissue thickness changes during the 1-year study period.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partially edentulous
- •Adult dental patients that require moderate 3-D bone augmentation for dental implant site improvement
排除标准
- •Poor oral hygiene indices for microbial plaque (PI) and gingival inflammation (GI)
- •Patients who have been on Chemotherapy or Radiation therapy within last 5 years.
- •Patients under active treatment with following medications: Bisphosphonates, Gabapentin, Glucocorticoids, Methotrexate, or Estrogen supplements.
- •Subjects under the direct supervision of the PI
- •Smoking more than 10 cigarettes per day
- •Uncontrolled diabetes or other metabolic disorders
研究组 & 干预措施
CAD-CAM Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with CAD-CAM designed and preprinted Ti-MESH during surgery.
干预措施: CAD-CAM designed and preprinted Ti-Mesh frame (Procedure)
Conventional Ti-Mesh frame
Participants randomized into this arm will have their tooth loss treated with conventional chairside fabrication of Ti-MESH during surgery.
干预措施: Conventional chairside fabrication of Ti-Mesh frame (Procedure)
结局指标
主要结局
Surgical exposure time for recipient site
时间窗: 5 minutes
Surgical exposure time will be measured for recipient site in minutes
Bone contour accuracy
时间窗: 5 months post op
Bone contour accuracy will be derived by merger of the post op Cone beam computed tomography (CBCT) DICOM file with the CBCT-1/CEREC-1/Virtual Implant file produced at the planning stage. Accuracy of fit will be calculated for volume and linear measures (4 sides of each implant-MDBL) horizontal and vertical from the implant restorative platform.
Total surgical time
时间窗: 2 hours
Total surgical time is defined as from incision time to completion of sutures and will be measured in minutes.
次要结局
- Ti-Mesh exposure incidence(1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks)
- Percentage of Vital bone(6 months)
- Ti-Mesh exposure size(1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks)
- Ti-Mesh exposure location(1 week, 2 weeks, 4weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks)