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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freehand | Active Comparator | Nobel Replace Conical Connection® placed 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Computer Assisted Surgery | Procedure | Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduard Valmaseda Castellón, PhD | University of Barcelona | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Barcelona | L'Hospitalet de Llobregat | Catalonia | 08903 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28000275 | Background | 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. | |
| 26452429 | 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. |
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Patients' personal data will not be published, however, the results of the scientific study will be published in a scientific dental journal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2023 | Aug 31, 2023 | ICF_000.pdf |
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|
| Freehand | Procedure | Freehand implant placement |
|
| 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:
|
| 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:
| 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 | 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. |
| 11673921 | 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. |
| 34245701 | 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. |
| 34698720 | 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. |
| 33635397 | 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. |
| 27267658 | 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. |
| 30573712 | 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. |
| 25123770 | Result | 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. |
| 16569960 | 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. |
| 41840319 | Derived | 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. |