Dynamic Navigation vs. the Freehand Method

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

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.
• To assess the association between SURG-TLX-SP scores and preoperative anxiety, self-perceived surgical difficulty, assistant-observed stress, and surgical duration in novice surgeons.

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.).