Study to Confirm Accuracy & Safety of the Inliant Surgical Navigation

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Partial Edentulism

Clinical Trial Details

NCT number	NCT03934853
Study type	Interventional
Source	Navigate Surgical Technologies Inc.
Contact
Status	Completed
Phase	N/A
Start date	May 29, 2018
Completion date	March 12, 2019

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms