Accuracy of Dental Implant Placement Using Dynamic Navigation or the Freehand Method: a Randomized Controlled Clinical Trial in Novice Operators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- To evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.
研究概览
简要总结
The purpose of the study is to evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.
详细描述
Randomized clinical trial with 2 parallel treatment groups. Eligible patients will be randomized with a 1:1 ratio to one of 2 possible parallel treatment groups:
- Group 1: Nobel Replace Conical Connection® placed freehand.
- Group 2: Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA).
PRIMARY OBJECTIVE:
- To evaluate in novice surgeons the accuracy of the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who agree to voluntarily sign the informed consent before performing any action related to the study.
- •Men or women at least 18 years old.
- •Single edentulous spaces or edentulous sections located in maxilla or mandible with a healing period longer than 12 weeks to rehabilitate with implant-supported fixed crowns ≤3 units.
- •O'Leary plaque and/or bleeding on probing index ≤25%.
排除标准
- •Systemic diseases that may interfere with dental implant placement.
- •Any contraindications for oral surgical procedures.
- •History of head and neck radiotherapy.
- •Patients smoking >20 cigarettes/day or tobacco equivalents.
- •History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the opinion of the investigator, could interfere with the patient's ability to cooperate and comply with the study.
- •Patients who have participated in a clinical trial within the last 30 days.
- •Pregnant or lactating women.
- •Patients with poor or unmotivated oral hygiene.
- •Probing depth with bleeding of ≥4 mm in one of the teeth adjacent to the edentulous space or tract.
- •Need to perform guided bone regeneration procedures simultaneous to implant placement.
- •Cases where the use of transepithelial abutments is not recommended (reduced prosthetic space, high esthetic demand associated with thin gingival biotypes, etc.).
研究组 & 干预措施
Freehand
Nobel Replace Conical Connection® placed freehand
干预措施: Freehand (Procedure)
X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)
Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)
干预措施: Dynamic Computer Assisted Surgery (Procedure)
结局指标
主要结局
To evaluate in novice surgeons the accuracy of the X-Guide® navigation system (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) in implant placement compared to freehand implant placement.
时间窗: Through study completion, an average of 1 year.
The accuracy of placement of Nobel Replace Conical Connection® implants (Nobel Biocare) will be evaluated by superimposing the two cone-beam computed tomography (CBCT) (pre- and post-surgical) and calculating the deviations from the pre-operative planning and the final implant position. The superimposition of both CBCTs will be performed using X-Guide Standalone Planning Software (Nobel Biocare). The following variables will be analyzed for each implant: Angular deviation, Lateral platform deviation (2D), Global platform deviation (3D), Lateral apex deviation (2D), Apex depth deviation and Global apex deviation (3D).
次要结局
- Comparison of Patient Reported Outcomes Measures (PROMs) between navigated and freehand surgery, using the Oral Health Impact Profile questionnaire, in addition to a PROMs questionnaire designed.(The OHIP-14 will be performed just before starting the surgery and at the 7-day postoperative control. The PROMs questionnaire will be performed by the patient just after finishing the implant surgery and having explained the postoperative instructions.)
- Comparison of postoperative pain between navigated and freehand surgery, using a questionnaire designed with a visual analog scale (VAS).(The postoperative pain will be evaluated immediately after the surgery with a VAS questionnaire and during the 7 days following surgery.)
- To evaluate overall surgical time with the X-Guide® Navigation System (X-Guide®, X-Nav Technologies®, Pennsylvania, USA) compared to freehand implant placement in inexperienced surgeons.(During the surgical procedure.)
研究者
Octavi Camps-Font
Associate Professor of Oral Surgery
University of Barcelona