Dental Implants Clinical Trial
Official title:
Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial
This study consists in a randomized controlled trial which objective is to assess the accuracy of a dynamic navigation system in dental implant placement in partially edentulous patients compared with the conventional freehand method.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | February 2021 |
Est. primary completion date | January 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Partially edentulous patients that requires at least the placement of one dental implant - Healthy patients ASA I and II (American Society of Anesthesiologists classification) - Over 18 years old patients Exclusion Criteria: - Totally edentulous patients - Systemic or local conditions that contraindicates dental implant surgery - Patients with less than 3 teeth in the jaw. |
Country | Name | City | State |
---|---|---|---|
Spain | Universitat de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
University of Barcelona |
Spain,
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Epub 2016 Jun 6. — View Citation
Jorba-García A, Figueiredo R, González-Barnadas A, Camps-Font O, Valmaseda-Castellón 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. — View Citation
Jung RE, Schneider D, Ganeles J, Wismeijer D, Zwahlen M, Hämmerle CH, Tahmaseb A. Computer technology applications in surgical implant dentistry: a systematic review. Int J Oral Maxillofac Implants. 2009;24 Suppl:92-109. Review. — View Citation
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angular deviation | angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees | 3 months post operative | |
Primary | Platform 3D deviation | global deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm). | 3 months post operative | |
Primary | Apex 3D deviation | global deviation at the apex of the dental implant between the virtual planned position and the final position of the dental implant measured in the 3 axes of the space (3D deviation). Measured in millimeters (mm). | 3 months post operative | |
Primary | Platform 2D deviation | Lateral deviation at the platform of the dental implant between the virtual planned position and the final position of the dental implant measured in 2 axes of the space (x and y, 2D deviation). Measured in millimeters (mm). | 3 months post operative | |
Primary | Apex depth deviation | Depth deviation of the apex of the dental implant between the virtual planned position and the final position of the dental implant in the Z-axis. Measured in millimeters (mm). | 3 months post operative | |
Secondary | Patient-reported outcome measures (PROMs) questionnaire | Patients perception of their functional well-being and health status during the dental implant treatment with a navigation system. We will use OHIP-14 (Oral Health Impact Profile) questionnaire. | One week post operative. |
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