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出境医 / 临床实验 / Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System

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

Study Description
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
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
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

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
Tracking Information
First Submitted Date  ICMJE April 11, 2019
First Posted Date  ICMJE May 2, 2019
Last Update Posted Date May 2, 2019
Actual Study Start Date  ICMJE May 29, 2018
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019) 		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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System
Official Title  ICMJE Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Partial Edentulism
Intervention  ICMJE Device: Dynamic Dental Navigation
Aid in dental implant placement in humans
Study Arms  ICMJE No arm
There is no arm for this study.
Intervention: Device: Dynamic Dental Navigation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2019) 		53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 12, 2019
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03934853
Other Study ID Numbers  ICMJE CL-VAV-00862
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navigate Surgical Technologies Inc.
Study Sponsor  ICMJE Navigate Surgical Technologies Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nicholas M Makhoul McGill University
PRS Account Navigate Surgical Technologies Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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