The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Accuracy of Implant Placement
研究概览
简要总结
This study evaluates three different methods of dental implant surgery-freehand, pilot-drilled, and fully guided techniques-in patients with partial tooth loss (partial edentulism). Dental implants are widely used to restore missing teeth, but the success of these procedures depends heavily on accurate placement and surgical precision.
The study involves 90 participants, divided into three groups of 30, each undergoing one of the three surgical techniques. The main goals are to compare surgery duration, implant placement accuracy, post-operative recovery, patient satisfaction, and long-term success rates.
Key findings suggest that fully guided implant surgery offers the highest accuracy, the shortest recovery time, and the highest patient satisfaction. Pilot-drilled surgery also showed excellent results, providing a balance between precision and efficiency. Freehand surgery, while flexible, showed slightly lower accuracy and higher complication rates.
This research aims to guide patients and healthcare providers in selecting the most suitable implant surgery method for improved outcomes and long-term success in dental care.
详细描述
This randomized controlled trial will investigate the efficacy of three implant placement techniques-freehand, pilot-drilled, and fully guided-in patients with partial tooth loss. The study will explore critical factors such as surgical precision, patient recovery, implant stability, and overall satisfaction. The objective will be to provide evidence-based guidance for selecting optimal surgical techniques tailored to individual patient needs.
Study Design:
Participants: 90 partially edentulous patients will be randomly assigned into three groups (30 patients per group).
Techniques:
Freehand surgery: Surgeons will rely on their skill and judgment for implant placement without specialized guides.
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
- 是
入选标准
- •Adults aged 18-80 years.
- •Patients with partial edentulism (missing one or more teeth in an otherwise dentate arch).
- •Sufficient bone volume and quality to support implant placement without additional bone augmentation.
- •Good overall health with no systemic contraindications for surgery.
- •Willingness to provide informed consent and comply with the study protocol and follow-up visits.
排除标准
- •Patients with uncontrolled systemic conditions (e.g., diabetes, cardiovascular diseases) that may affect healing or surgery outcomes.
- •Pregnant or lactating women.
- •Smokers or individuals with a history of poor compliance with post-operative care.
- •Patients requiring additional bone grafting, sinus lifts, or complex augmentation procedures for implant placement.
- •Active oral infections, untreated periodontal disease, or severe malocclusion that could interfere with implant placement or outcomes.
- •Patients with a history of bisphosphonate use or other medications known to affect bone metabolism.
- •Individuals with mental or physical conditions that would impair their ability to participate in the study or follow the protocol.
研究组 & 干预措施
Freehand Implant Surgery
Participants in this arm will undergo implant placement using the freehand technique. This approach relies on the surgeon's clinical judgment and visual landmarks for implant positioning without the use of specialized guides.
干预措施: Freehand Implant Surgery (Procedure)
Pilot-Drilled Implant Surgery
Participants in this arm will undergo implant placement using the pilot-drilled technique. A pilot drill will be used to create an initial guided pathway for the implant, improving placement accuracy while allowing for some flexibility during the procedure.
干预措施: Fully Guided Implant Surgery (Procedure)
Fully Guided Implant Surgery
Participants in this arm will undergo implant placement using the fully guided technique. This approach utilizes computer-aided surgical templates created from preoperative imaging to ensure precise implant positioning, angulation, and depth
干预措施: Pilot-Drilled Implant Surgery (Procedure)
结局指标
主要结局
Accuracy of Implant Placement
时间窗: Immediately post-surgery
Accuracy of implant positioning will be assessed using postoperative radiographic imaging (CBCT) to measure deviations in angulation, depth, and position from the preoperative plan.
Postoperative Complication
时间窗: Within 2 weeks post-surgery
Incidence of complications such as bleeding, infection, nerve damage, or soft tissue trauma will be recorded.
次要结局
- Surgery Duration(During the surgical procedure)
- Pain Levels(Days 1, 3, and 7 post-surgery)
- Implant Stability(At 3, 6, and 12 months post-surgery)
研究者
Sunil Kumar Vaddamanu
Assistant Professor
King Khalid University