Assessing the Role of 3D-Printed Surgical Guides in Enhancing Dental Implant Placement Precision and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- primary stability improvement
研究概览
简要总结
The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement. The research objective is to assess and compare the clinical outcomes of guided surgical implants placement versus conventional freehand implant placement, focusing on primary implant stability, secondary implant stability and postoperative pain. In alignment with this objective, the aim of this study is to compare the clinical outcomes: as implant primary and secondary stability and postoperative pain between guided surgical implant placement and conventional freehand surgical implant placement.
Hypothesis of the study This study hypothesized that guided implant surgery will result in superior implant stability outcome and reduced postoperative pain compared to the freehand technique High light of study. The use of advance technology (machines and software programs) to enhance implant survival and reduce surgical complications associated with implant placement. It is worth noting that, a fully guided implant placement provides flapless surgery and the implant positions were virtually planned based on anatomical and prosthetic considerations. The use of Easy Check Implant Stability Measuring System for measuring primary and secondary implant stability.
详细描述
Background: The precision of dental implant placement is vital for long-term implant success. The surgical guide is designed using advanced 3D imaging techniques allows for a highly accurate simulation of the ideal implant position, angulation, and depth based on the patient's unique anatomy. The aim of the study is to compare implant stability and postoperative pain between guided and freehand surgical implant placement.
Methods: randomized controlled clinical study included 30 patients with a total of 30 implants were placed and analyzed. All patients were randomly allocated into two groups: Test Group (Guided Surgery Group) and Control Group (Freehand Surgery Group). For all the patient in the study primary stability was assessed immediately after implant placement and secondary stability was assessed three months postoperatively. Postoperative pain was measured using the (VAS), immediately after surgery and one week later.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The inclusion criteria for the study were:
- •Patients ≥18 years of age.
- •Presenting with maxillary tooth loss,
- •Tooth extraction at least 3 months before (delayed placement)
- •Adequate amount of bone volume to place the implant without bone augmentation (2 mm bone circumferentially around the implant).
排除标准
- •for the study were: Patients were excluded from the study for the following reasons:
- •General contraindications to implant surgery;
- •Patients with history of chemo or radiotherapy;
- •Poor oral hygiene;
- •Pregnant or lactating women;
- •Uncontrolled diabetic patients.
研究组 & 干预措施
Test Group (Guided Surgery Group)
Test Group (Guided Surgery Group): Implants were placed using 3D-printed surgical guides
干预措施: All implant placements were performed exclusively in the maxillary region (upper jaw) to ensure a controlled comparison within the same anatomical area (Procedure)
Control Group (Freehand Surgery Group)
Implants were placed freehand without guide assistance
结局指标
主要结局
primary stability improvement
时间窗: For all the patient in the study primary stability was assessed immediately after implant placement
For all the patient in the study primary stability was assessed postoperatively using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability
post operative pain
时间窗: From placement of implant immediately and to the 2nd visit of treatment at one week
Postoperative pain was measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), immediately after surgery and one week later
post operative pain
时间窗: From placement of implant immediately and to the 2nd visit of treatment at one week
Postoperative pain was measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain), immediately after surgery and one week later
primary stability improvement
时间窗: For all the patient in the study primary stability was assessed immediately after implant placement
For all the patient in the study primary stability was assessed postoperatively using ISQ. The Scale Implant Stability Quotient (ISQ) range between 1 to 100. The Interpretation of scores as follow: ISQ \>70: High stability ISQ 60-69: Moderate stability ISQ \<60: Low stability
次要结局
- secondary stability outcome measure(For all the patient in the study, the secondary stability was assessed three months from implant placement)
- secondary stability outcome measure(For all the patient in the study, the secondary stability was assessed three months from implant placement)
研究者
Munib Abdullah Fathi
Assist.Prof.Dr. Munib Abdullah Fathi
University of Mosul