NCT03934853

Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System

Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Navigate Surgical Technologies Inc. · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

A confirmatory dual-clinic, non-randomized study of the Inliant device to aid in dental implant placement in humans. The hypothesis is that using the Inliant Surgical Navigation System ("Inliant") will provide a high degree of accuracy in multiple dimensions relative to the ideal implant position as determined in the planning stage, and will not result in any adverse outcomes related to use of the device. Five clinicians (Investigators) of various clinical backgrounds and experience will use the Inliant device, a licensed, medical device in Canada, to place a dental implant in a total of twenty (20) subjects.

Detailed description

The long term success of dental implant therapy is largely dependent on proper implant positioning in bone, and the facilitation of a well-functioning prosthesis. Surgical complications from implant placement in an incorrect location can include damage to adjacent teeth, sinus perforations, hemorrhage, buccal plate dehiscence, and nerve damage. In implant therapy, dynamic surgical guidance is a new technology used to facilitate accurate and efficient implant placement, and to aid in communication between the restorative dentist and surgeon. The Inliant device is a dynamic surgical navigation system that is based on passive optical tracking technology. Passive optical tracking is accomplished by having the patient wear a reference body that is identified by an optical tracking system. This information allows the clinician to visualize the surgical drill projected onto a screen, showing its position in 3 dimensions on a CBCT scan of the patient. Dynamic surgical guidance has additional advantages over traditional methods in that it allows for intra-operative changes in implant planning, and allows the clinician to visualize the position of the surgical drill during the procedure. The purpose of the present study is to analyze the accuracy of the Inliant device as a method of placing dental implants in an actual clinical setting and to confirm its safety.

Conditions

• Partial Edentulism

Interventions

Type	Name	Description
DEVICE	Dynamic Dental Navigation	Aid in dental implant placement in humans

Timeline

• Start date: 2018-05-29
• Primary completion: 2019-01-14
• Completion: 2019-03-12
• First posted: 2019-05-02
• Last updated: 2019-05-02

Locations

1 site across 1 country: Canada