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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03934853
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
Navigate Surgical Technologies Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Partial Edentulism Device: Dynamic Dental Navigation Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement
Actual Study Start Date : May 29, 2018
Actual Primary Completion Date : January 14, 2019
Actual Study Completion Date : March 12, 2019
Arms and Interventions
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Arm Intervention/treatment
No arm
There is no arm for this study.
 Device: Dynamic Dental Navigation
Aid in dental implant placement in humans


Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of implant placement [ Time Frame: +/- 7 days of implant procedure ]
    Uses passive optical tracking technology pre-operatively to plan dental implant placement. Uses the same technology post-operatively for placement comparison assessment.


Secondary Outcome Measures :
  1. Safety assessment through collection of adverse event data [ Time Frame: +/- 7 days of implant procedure ]
    Assessment of safety in a clinical environment as determined by review of adverse events related to the use of the device


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide signed and dated informed consent form (ICF)
  • Willing to comply with all study procedures and be available for the study
  • Male or female, 22 years of age and older
  • In good general health as evidenced by medical history
  • To provide attachment of the stent for each implant, there must be at least two adjacent zero mobility teeth anywhere in the same arch on which the surgery is to be performed

Exclusion Criteria:

  • A medical condition, psychological condition or dental condition that would exclude a patient from having dental implant surgery. Example: inability to tolerate local anesthesia or other dental disease conditions that would preclude dental implant surgery.
  • Use of disallowed concomitant medications (only if a contraindication to dental implant surgery. Examples include long term bisphosphonates, high dose blood thinners, etc.).
  • Pregnancy
  • Treatment with another investigational drug or other intervention
  • Inability to obtain a suitable pre-operative CBCT scan
  • In surgery, if there are clinical conditions that unexpectedly do not allow for the placement of an implant, e.g. lack of primary stability during immediate placement.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03934853


Locations
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Canada, Quebec
McGill University Health Center
Montreal, Quebec, Canada
Sponsors and Collaborators
Navigate Surgical Technologies Inc.
Investigators
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Principal Investigator: Nicholas M Makhoul McGill University
More Information
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Responsible Party: Navigate Surgical Technologies Inc.
ClinicalTrials.gov Identifier: NCT03934853    
Other Study ID Numbers: CL-VAV-00862
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No