Partial Edentulism Clinical Trial
Official title:
Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement
Verified date | April 2019 |
Source | Navigate Surgical Technologies Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 53 |
Est. completion date | March 12, 2019 |
Est. primary completion date | January 14, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Center | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Navigate Surgical Technologies Inc. |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Safety assessment through collection of adverse event data | Assessment of safety in a clinical environment as determined by review of adverse events related to the use of the device | +/- 7 days of implant procedure |
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