NCT04344808

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

9 months

First QC Date

March 30, 2020

Last Update Submit

April 9, 2020

Conditions

Surgery, Computer-AssistedDental Implants

Keywords

Surgery, Computer-AssistedDental ImplantsNavigation systemDynamic computer-assisted surgeryImplantology

Outcome Measures

Primary Outcomes (5)

  • Angular deviation

    angular deviation between the virtual planed position of the implant and the final implant position. Measured in degrees

    3 months post operative

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Patient-reported outcome measures (PROMs) questionnaire

    One week post operative.

Study Arms (2)

Navigation group

EXPERIMENTAL

Dental implants will be placed using a dynamic computer assisted surgery system

Device: Dynamic navigation system

Freehand group

ACTIVE COMPARATOR

Dental implants will be place without any guidance. Only virtually planning the ideal position on a 3D image (Cone beam computed tomography)

Device: Freehand implant placement

Interventions

Dynamic navigation systemDEVICE

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.

Also known as: Dynamic computer assisted surgery
Navigation group
Freehand implant placementDEVICE

Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done

Also known as: Non-guided implant placement
Freehand group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Totally edentulous patients
  • Systemic or local conditions that contraindicates dental implant surgery
  • Patients with less than 3 teeth in the jaw.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat de Barcelona

Barcelona, 08907, Spain

Location

Related Publications (7)

  • 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.

    PMID: 25123770BACKGROUND

  • 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.

    PMID: 31829457BACKGROUND

  • 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.

    PMID: 28000275BACKGROUND

  • 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.

    PMID: 30573712BACKGROUND

  • 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.

    PMID: 26452429BACKGROUND

  • 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.

    PMID: 27267658BACKGROUND

  • 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.

    PMID: 19885437BACKGROUND

Study Officials

  • Adrià Jorba-García

    University of Barcelona

    PRINCIPAL INVESTIGATOR

  • Rui Figueiredo

    University of Barcelona

    STUDY DIRECTOR

  • Eduard Valmaseda-Castellón

    University of Barcelona

    STUDY CHAIR

  • Octavi Camps-Font

    University of Barcelona

    STUDY CHAIR

  • Javier Bara-Casaus

    University of Barcelona

    STUDY CHAIR

Central Study Contacts

Adrià Jorba-García, DDS

CONTACT

0034 699183949adriajorba@hotmail.com

Rui Figueiredo

CONTACT

ruipfigueiredo@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Patient will be unaware of which group since during the surgical procedure patient eyes' will be covered. Outcome assessor won't take part of the clinical process and will be blinded regarding which group is allocated each patient.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor. PhD, MD, DDS

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 14, 2020

Study Start

April 1, 2020

Primary Completion

January 1, 2021

Study Completion

February 1, 2021

Last Updated

April 14, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)