Dynamic Navigation vs. the Freehand Method

May 13, 2026 updated by: Octavi Camps-Font, University of Barcelona

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalonia
      • L'Hospitalet de Llobregat, Catalonia, Spain, 08903
        • University of Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Freehand
Nobel Replace Conical Connection® placed freehand
Procedure: Freehand
Freehand implant placement
Experimental: 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)
Procedure: Dynamic Computer Assisted Surgery
Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide
Other Names:
  • Dynamic Navigation
  • Navigated surgery

What is the study measuring?

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.
Time Frame: 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).
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.
Time Frame: During the surgical procedure.
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.
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.

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).
Time Frame: The postoperative pain will be evaluated immediately after the surgery with a VAS questionnaire and during the 7 days following surgery.

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.
Assessment of correlations between perceived surgical workload and preoperative anxiety, self-perceived surgical difficulty, assistant-observed stress, and surgical duration in novice surgeons
Time Frame: From immediately before surgery to immediately after completion of the surgical procedure.
Correlations between perceived surgical workload and other perioperative variables will be assessed during implant placement procedures performed by novice surgeons. Perceived surgical workload will be measured using the Spanish version of the Surgery Task Load Index questionnaire (SURG-TLX-SP; total score and domain scores). Preoperative anxiety will be assessed immediately before surgery using the State-Trait Anxiety Inventory-State questionnaire (STAI-S; score). Self-perceived surgical difficulty will be assessed immediately after surgery using a 100 mm visual analog scale (VAS; mm). Assistant-observed operator stress will be evaluated immediately after surgery using a 100 mm VAS completed by the surgical assistant (mm). Surgical duration will be recorded in minutes from the beginning of the incision to placement of the last suture (minutes). Correlations between SURG-TLX-SP scores and each variable will be analyzed.
From immediately before surgery to immediately after completion of the surgical procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Investigators

  • Study Chair: Eduard Valmaseda Castellón, PhD, University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2023

Primary Completion (Actual)

July 16, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

August 31, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RCT X-GUIDE (50/2022)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patients' personal data will not be published, however, the results of the scientific study will be published in a scientific dental journal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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