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.
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: * 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. * To evaluate Patient Reported Outcomes Measures (PROMs) during implant treatment with navigation systems performed by novice surgeons.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
60
Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide
Freehand implant placement
University of Barcelona
L'Hospitalet de Llobregat, Catalonia, Spain
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.
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).
Time frame: Through study completion, an average of 1 year.
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.
Duration of the operation from the moment of anesthesia to the last suture point. In seconds (s).
Time frame: During the surgical procedure.
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.
A questionnaire has been designed to evaluate the PROMs of patients treated with dynamic guided surgery and compare it with the PROMs of patients treated freehand: * Prior to surgery the patient will complete the oral health impact profile questionnaire (OHIP-14sp). * Immediately after the surgery and after explaining the postoperative instructions, the patient will fill in the questionnaire designed to evaluate PROMs. * At 7 postoperative days, the patient will again complete the OHIP-14sp.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Comparison of postoperative pain between navigated and freehand surgery, using a questionnaire designed with a visual analog scale (VAS).
A questionnaire has been designed to evaluate the postoperative pain of patients treated with dynamic guided surgery and compare it with patients treated freehand: * Immediately after the surgery the patient will complete the VAS questionnaire. * Another VAS questionnaire will be given to assess postoperative pain during the 7 days following surgery. * The VAS questionnaire consists of a 100 mm visual analog scale (VAS). In the VAS questionnaire given for the 7 postoperative days there will be a VAS for each day and the analgesics and anti-inflammatory drugs consumed by the patient will be recorded. * The VAS is formed by the value "No pain" to the left of the 100 mm straight line and by the value "Worst pain imaginable" to the right of the 100 mm straight line.
Time frame: The postoperative pain will be evaluated immediately after the surgery with a VAS questionnaire and during the 7 days following surgery.