An interventional study of Dynamic Dental Navigation in Partial Edentulism, sponsored by Navigate Surgical Technologies Inc.. Completed at 1 site in Canada. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2019-05-02.
Sponsored by Navigate Surgical Technologies Inc. · Not applicable, Interventional, and Other
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.
This is the only study on the registry with Navigate Surgical Technologies Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
There is no arm for this study.
Device: Dynamic Dental Navigation
Aid in dental implant placement in humans
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.
Time frame: +/- 7 days of implant procedure
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
Time frame: +/- 7 days of implant procedure
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.