Partial Edentulism Clinical Trial
Official title:
Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement
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.
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.
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