Assessment of Two Implant Placement Protocols to Evaluate Placement Accuracy and Post-Operative Healing
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Radiographic marginal bone loss
研究概览
简要总结
The goal of this study is to evaluate two commonly utilized surgical guide protocols to determine dental implant placement accuracy compared to pre-operative computerized planning, post-operative healing and bone levels to 12-months post-placement, and patient assessed post-operative discomfort and healing using a visual acuity scale (VAS).
详细描述
This proposed study would allow us to assess the use of two intraoperative surgical guide protocols in common use in dental practice (matrix-based pilot drill guided and fully digital guided) for implant placement surgical procedure.
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)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •At least 18 years old
- •Must be a patient of the UAB Dental School
- •Able to read and understand informed consent document
- •Patients presenting with a single edentulous site planned for dental implant placement
- •Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of edentulous site planned for dental implant placement.
- •No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.
排除标准
- •Non-English speaking
- •Less than 18 years old
- •Smokers/tobacco users (>10 cigarettes/day)
- •Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- •Absence of adjacent teeth/implants on either side of the tooth to be extracted and/or edentulous sites where 2 or more adjacent implants are planned.
研究组 & 干预措施
Pilot Drill Guide (PDG)
Matrix-based pilot drill guides fabricated using casts derived from digital wax ups of the proposed final restoration based upon initial implant planning and will be placed using the standard manufacturer's protocol.
干预措施: Pilot Drill Guide (PDG) (Procedure)
Fully Guided (FG
3-D printed guides fabricated based upon digital wax ups and will be placed using the standard manufacturer's protocol and guided implant placement kits
干预措施: Fully Guided (FG) (Procedure)
结局指标
主要结局
Radiographic marginal bone loss
时间窗: From baseline to 12 months
Radiographic marginal bone loss as measured using digital measurement tools and calibrated parallel two-dimensional radiographic images from baseline dental implant placement to 12-months post-implant placement
Patient centered outcomes using the Visual Analog Scale (VAS
时间窗: 4 weeks
Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 7, 14, and 30 days postoperatively, using the Visual Analog Scale (VAS) This measurement ranges from 0-10 (0 being better and 10 being worse).
Implant placement deviation from computerized planning
时间窗: 12 months
Implant placement deviation from computerized planning at 12-month post-placement using CBCT overlay measurement techniques.
次要结局
未报告次要终点
研究者
Maria L. Geisinger, DDS, MS
Chair, Professor
University of Alabama at Birmingham