Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2023-09-08
2024-11-01
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Freehand
Nobel Replace Conical Connection® placed freehand
Freehand
Freehand implant placement
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)
Dynamic Computer Assisted Surgery
Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide
Interventions
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Dynamic Computer Assisted Surgery
Surgical navigation system (X-Guide guided surgery system) Navigation system X-Guide
Freehand
Freehand implant placement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.).
18 Years
ALL
Yes
Sponsors
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University of Barcelona
OTHER
Responsible Party
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Octavi Camps-Font
Associate Professor of Oral Surgery
Principal Investigators
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Eduard Valmaseda Castellón, PhD
Role: STUDY_CHAIR
University of Barcelona
Locations
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University of Barcelona
L'Hospitalet de Llobregat, Catalonia, Spain
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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RCT X-GUIDE (50/2022)
Identifier Type: -
Identifier Source: org_study_id
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