Dynamic Navigation vs. the Freehand Method

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Accuracy of Dental Implant Placement Using Dynamic Navigation or the Freehand Method: a Randomized Controlled Clinical Trial in Novice Operators

Conditions
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Dental Implants

Intervention / Treatment
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* Procedure: Dynamic Computer Assisted Surgery
* Procedure: Freehand


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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%. Exclusion Criteria: 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.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Freehand<br>Nobel Replace Conical Connection® placed freehand | Procedure: Freehand<br>* Freehand implant placement<br>|
| Experimental: X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)<br>Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA) | Procedure: Dynamic Computer Assisted Surgery<br>* Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide<br>* Other names: Navigated surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Through study completion, an average of 1 year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | 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). | 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. | The postoperative pain will be evaluated immediately after the surgery with a VAS questionnaire and during the 7 days following surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynamic computer assisted implant surgery