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

NCT03934853 | Completed

• 1 other identifier: CL-VAV-00862
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Partial Edentulism

Outcome Measures

Primary Outcomes (1)

• Accuracy of implant placement

  Uses passive optical tracking technology pre-operatively to plan dental implant placement. Uses the same technology post-operatively for placement comparison assessment.

  +/- 7 days of implant procedure

Secondary Outcomes (1)

• Safety assessment through collection of adverse event data

  +/- 7 days of implant procedure

Study Arms (1)

No arm

OTHER

There is no arm for this study.

Device: Dynamic Dental Navigation

Interventions

Dynamic Dental Navigation DEVICE

Aid in dental implant placement in humans

No arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navigate Surgical Technologies Inc.: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, Canada

Location

Study Officials

• Nicholas M Makhoul

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: May 2, 2019
• Study Start: May 29, 2018
• Primary Completion: January 14, 2019
• Study Completion: March 12, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Locations

CA (1)