AzTrials
AzTrials

Dental ImplantsNCT06028750

Dynamic Navigation vs. the Freehand Method

A study testing Dynamic Computer Assisted Surgery and Freehand in people with Dental Implants, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Implants
What is being tested?
Dynamic Computer Assisted Surgery and Freehand
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSpain
Study dates
8 Sep 2023to 1 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.).

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • University of Barcelona

    L'Hospitalet de Llobregat, Catalonia, 08903

Other trials in Spain

About this study

Official title: 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.

Read the 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.
Conditions
Dental Implants
Being tested
Dynamic Computer Assisted Surgery, Freehand
Keywords
Dynamic computer assisted implant surgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Computer Assisted SurgeryProcedure or surgery

    Also called Dynamic Navigation, Navigated surgery

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

  • FreehandProcedure or surgery

    Freehand implant placement

Study groups in NCT06028750
Study groupRoleWhat they receive
FreehandActive comparatorNobel Replace Conical Connection® placed freehand
Receives: Procedure: Freehand
X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)ExperimentalNobel Replace Conical Connection® placed using the X-Guide guided surgery system (X-Nav Technologies®, Pennsylvania, USA)
Receives: Procedure: Dynamic Computer Assisted Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Through study completion, an average of 1 year.

Secondary outcomes (4)
  1. 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).

    Measured: During the surgical procedure.

  2. 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.

    Measured: 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.

  3. 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.

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

  4. Assessment of correlations between perceived surgical workload and preoperative anxiety, self-perceived surgical difficulty, assistant-observed stress, and surgical duration in novice surgeons

    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.

    Measured: From immediately before surgery to immediately after completion of the surgical procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2023
  2. Study start8 Sep 2023
  3. Primary completion16 Jul 2024
  4. Study completion1 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06028750
Sponsor's protocol ID
RCT X-GUIDE (50/2022)
Status last verified
May 2026
First submitted
8 May 2023
Last updated
18 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Patients' personal data will not be published, however, the results of the scientific study will be published in a scientific dental journal.

Publications

  • 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.

    PubMed 28000275
  • 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.

    PubMed 26452429
  • 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.

    PubMed 11673921
  • 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.

    PubMed 34245701
  • 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.

    PubMed 34698720
  • 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.

    PubMed 33635397
  • 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.

    PubMed 27267658
  • 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.

    PubMed 30573712
  • 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.

    PubMed 25123770
  • 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.

    PubMed 16569960
  • Ruiz-Romero V, Camps-Font O, Jorba-Garcia A, Sanchez-Torres A, Figueiredo R, Valmaseda-Castellon E. Trueness of Dental Implant Placement Using Dynamic Navigation or Non-Guided Approach by Novice Surgeons: A Randomized, Controlled Clinical Trial. Clin Oral Implants Res. 2026 Jun;37(6):770-782. doi: 10.1111/clr.70119. Epub 2026 Mar 16.

    PubMed 41840319

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Computer Assisted Surgery and Freehand in people with Dental Implants, run by University of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06028750, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in