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临床试验/NCT06764784
NCT06764784
已完成
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The Efficacy of Freehand, Pilot Drilled and Fully Guided Implant Surgery in Partially Edentulous Patients: a Randomize Control Trial

King Khalid University1 个研究点 分布在 1 个国家目标入组 90 人2024年1月6日

概览

阶段
不适用
干预措施
Freehand Implant Surgery
疾病 / 适应症
Partial Edentulism Class 1
发起方
King Khalid University
入组人数
90
试验地点
1
主要终点
Accuracy of Implant Placement
状态
已完成
最后更新
3个月前

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. Pilot-drilled surgery: Surgeons will use a pilot drill to create an initial guided pathway for implant placement. Fully guided surgery: Computer-aided templates will be utilized for precise positioning based on preoperative imaging and planning. Outcomes Measured: Surgical Parameters: Duration of surgery. Intraoperative complications. Postoperative Recovery: Pain, swelling, and healing responses. Implant Stability and Osseointegration: Radiographic imaging and resonance frequency analysis will assess outcomes at 3, 6, and 12 months. Patient Satisfaction: Surveys will measure aesthetics, comfort, and satisfaction with treatment outcomes. Long-term Success Rates: Implant survival rates and peri-implant bone health will be evaluated. Key Findings: Fully guided surgery is expected to demonstrate superior accuracy, reduced recovery times, and the highest patient satisfaction. Pilot-drilled surgery is anticipated to offer a robust balance of precision and efficiency, with high implant survival rates. Freehand surgery may show slightly lower success rates and higher variability in outcomes.

注册库
clinicaltrials.gov
开始日期
2024年1月6日
结束日期
2024年2月6日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Sunil Kumar Vaddamanu

Assistant Professor

King Khalid University

入排标准

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

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

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

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)

研究点 (1)

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