Dynamic Navigation System in Implantology

Dental Implants Clinical Trial

Official title:

Accuracy and Patient-Reported Outcome Measures (PROMs) of a Dynamic Navigation System in Implantology: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04344808
• Other study ID #: NavigationSystem
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2020
• Est. completion date: February 2021

Study information

• Verified date: April 2020
• Source: University of Barcelona
• Contact: Adrià Jorba-García, DDS
• Phone: 0034 699183949
• Email: adriajorba[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective randomized clinical trial.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Dental Implants
• Surgery, Computer-Assisted

Intervention

Device:
• 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

Locations

Country	Name	City	State
Spain	Universitat de Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (7)

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

Outcome

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.