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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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-04-30
2021-02-28
Brief Summary
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Detailed Description
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Each patient enrolled in this trial will be randomly allocated to one group ( Navigation group or Freehand groups). Preoperative virtual planification of dental implants on a pre-acquired cone beam computed tomography (CBCT) will be performed for each patient using the same system.
During the surgical phase, depending on which group is allocated the patient one surgical approach or other will be used. Then after the surgical procedure a PROMs questionnaire will be asked to the patients.
Finally a postoperative CBCT will be performed and overlapped with the preoperative CBCT (with the implants planification) and implant position deviations between the planned and final position will be measured.
The study devices are CE- (Conformité Européenne, meaning European Conformity) marked products and used within their intended use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
Study Groups
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Navigation group
Dental implants will be placed using a dynamic computer assisted surgery system
Dynamic navigation system
The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.
Freehand group
Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography)
Freehand implant placement
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
Interventions
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Dynamic navigation system
The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.
Freehand implant placement
Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy patients ASA I and II (American Society of Anesthesiologists classification)
* Over 18 years old patients
Exclusion Criteria
* Systemic or local conditions that contraindicates dental implant surgery
* Patients with less than 3 teeth in the jaw.
18 Years
ALL
Yes
Sponsors
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University of Barcelona
OTHER
Responsible Party
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Rui Figueiredo
Associate Professor. PhD, MD, DDS
Principal Investigators
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Adrià Jorba-García
Role: PRINCIPAL_INVESTIGATOR
University of Barcelona
Rui Figueiredo
Role: STUDY_DIRECTOR
University of Barcelona
Eduard Valmaseda-Castellón
Role: STUDY_CHAIR
University of Barcelona
Octavi Camps-Font
Role: STUDY_CHAIR
University of Barcelona
Javier Bara-Casaus
Role: STUDY_CHAIR
University of Barcelona
Locations
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Universitat de Barcelona
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
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.
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.
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.
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.
Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hammerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109.
Other Identifiers
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NavigationSystem
Identifier Type: -
Identifier Source: org_study_id
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