Dynamic Navigation vs. the Freehand Method

NCT06028750 | Completed

• 1 other identifier: RCT X-GUIDE (50/2022)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Implants

Keywords

Dynamic computer assisted implant surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

Study Arms (2)

Freehand

ACTIVE COMPARATOR

Nobel Replace Conical Connection® placed freehand

Procedure: Freehand

X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)

EXPERIMENTAL

Nobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)

Procedure: Dynamic Computer Assisted Surgery

Interventions

Dynamic Computer Assisted Surgery PROCEDURE

Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide

Also known as: Dynamic Navigation, Navigated surgery

X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)

Freehand PROCEDURE

Freehand implant placement

Freehand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

University of Barcelona

L'Hospitalet de Llobregat, Catalonia, 08903, Spain

Location

Related Publications (10)

• D'haese J, Ackhurst J, Wismeijer D, De Bruyn H, Tahmaseb A. Current state of the art of computer-guided implant surgery. Periodontol 2000. 2017 Feb;73(1):121-133. doi: 10.1111/prd.12175.

  PMID: 28000275 BACKGROUND

• Block MS, Emery RW. Static or Dynamic Navigation for Implant Placement-Choosing the Method of Guidance. J Oral Maxillofac Surg. 2016 Feb;74(2):269-77. doi: 10.1016/j.joms.2015.09.022. Epub 2015 Sep 30.

  PMID: 26452429 BACKGROUND

• Gaggl A, Schultes G, Karcher H. Navigational precision of drilling tools preventing damage to the mandibular canal. J Craniomaxillofac Surg. 2001 Oct;29(5):271-5. doi: 10.1054/jcms.2001.0239.

  PMID: 11673921 BACKGROUND

• Wang F, Wang Q, Zhang J. Role of Dynamic Navigation Systems in Enhancing the Accuracy of Implant Placement: A Systematic Review and Meta-Analysis of Clinical Studies. J Oral Maxillofac Surg. 2021 Oct;79(10):2061-2070. doi: 10.1016/j.joms.2021.06.005. Epub 2021 Jun 10.

  PMID: 34245701 BACKGROUND

• Pellegrino G, Ferri A, Del Fabbro M, Prati C, Gandolfi MG, Marchetti C. Dynamic Navigation in Implant Dentistry: A Systematic Review and Meta-analysis. Int J Oral Maxillofac Implants. 2021 Sep-Oct;36(5):e121-e140. doi: 10.11607/jomi.8770.

  PMID: 34698720 BACKGROUND

• Jorba-Garcia A, Gonzalez-Barnadas A, Camps-Font O, Figueiredo R, Valmaseda-Castellon E. Accuracy assessment of dynamic computer-aided implant placement: a systematic review and meta-analysis. Clin Oral Investig. 2021 May;25(5):2479-2494. doi: 10.1007/s00784-021-03833-8. Epub 2021 Feb 26.

  PMID: 33635397 BACKGROUND

• Emery RW, Merritt SA, Lank K, Gibbs JD. Accuracy of Dynamic Navigation for Dental Implant Placement-Model-Based Evaluation. J Oral Implantol. 2016 Oct;42(5):399-405. doi: 10.1563/aaid-joi-D-16-00025. Epub 2016 Jun 6.

  PMID: 27267658 BACKGROUND

• Jorba-Garcia A, Figueiredo R, Gonzalez-Barnadas A, Camps-Font O, Valmaseda-Castellon E. Accuracy and the role of experience in dynamic computer guided dental implant surgery: An in-vitro study. Med Oral Patol Oral Cir Bucal. 2019 Jan 1;24(1):e76-e83. doi: 10.4317/medoral.22785.

  PMID: 30573712 BACKGROUND

• Vercruyssen M, Fortin T, Widmann G, Jacobs R, Quirynen M. Different techniques of static/dynamic guided implant surgery: modalities and indications. Periodontol 2000. 2014 Oct;66(1):214-27. doi: 10.1111/prd.12056.

  PMID: 25123770 RESULT

• Miller RJ, Bier J. Surgical navigation in oral implantology. Implant Dent. 2006 Mar;15(1):41-7. doi: 10.1097/01.id.0000202637.61180.2b.

  PMID: 16569960 RESULT

Study Officials

• Eduard Valmaseda Castellón, PhD

  University of Barcelona

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Oral Surgery

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: September 8, 2023
• Study Start: September 8, 2023
• Primary Completion: July 16, 2024
• Study Completion: November 1, 2024
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)