Partial EdentulismNCT03934853
Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System
A study testing Dynamic Dental Navigation in people with Partial Edentulism, run by Navigate Surgical Technologies Inc. at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Dynamic Dental Navigation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteCanada
- Study dates
- 29 May 2018to 12 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Partial Edentulism
- Being tested
- Dynamic Dental Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Dental NavigationDevice
Aid in dental implant placement in humans
| Study group | Role | What they receive |
|---|---|---|
| No arm | Other | There is no arm for this study. Receives: Device: Dynamic Dental Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: +/- 7 days of implant procedure
Secondary outcomes (1)
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
Measured: +/- 7 days of implant procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start29 May 2018
- Primary completion14 Jan 2019
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Navigate Surgical Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas M Makhoul, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934853
- Sponsor's protocol ID
- CL-VAV-00862
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Clinical Study to Confirm Accuracy and Safety of the Inliant Surgical Navigation System for Dental Implant Placement
- ClinicalTrials.gov ID
- NCT03934853
- Acronym / sponsor ID
- CL-VAV-00862
- Conditions
- Partial Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Navigate Surgical Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 14 Jan 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No arm | Other | Device: Dynamic Dental NavigationThere is no arm for this study. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Dental NavigationAid in dental implant placement in humans | Device | No arm |
Primary outcome
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.
1 secondary outcome
Safety assessment through collection of adverse event data
Time frame: +/- 7 days of implant procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas M Makhoul principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Dental Navigation in people with Partial Edentulism, run by Navigate Surgical Technologies Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of implant placement (time frame: +/- 7 days of implant procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.