Dental Implants, Surgery, ComputersNCT03471208
Dynamic Navigation-Assisted Dental Implant Placement
A study testing Dynamic Navigation Assisted Implant Surgery and Freehand Implant Surgery in people with Dental Implants, Surgery, Computers, run by Istanbul University.
Trial summary
Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Surgery, Computers
- What is being tested?
- Dynamic Navigation Assisted Implant Surgery and Freehand Implant Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- men and women aged >18 years.
- Patients approving to participate in the trial and giving written consent
- must be able to open his/her mouth
Who cannot join
- Hemodynamically significant mitral valve stenosis
- Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
- Planned cardioversion (electrical or pharmacological)
- Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion)
- Known presence of atrial myxoma or left ventricular thrombus
- Active endocarditis
About this study
Official title: Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand
Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach.
All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.
- Conditions
- Dental Implants, Surgery, Computers
- Being tested
- Dynamic Navigation Assisted Implant Surgery, Freehand Implant Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Navigation Assisted Implant SurgeryDevice
Implant surgery using dynamic navigation assistance
Freehand Implant SurgeryProcedure or surgery
Also called Dental implant surgery via conventional freehand
Dental implant surgery via conventional freehand
| Study group | Role | What they receive |
|---|---|---|
| Dynamic Navigation | Experimental | Dental implant surgery via dynamic navigation assistance Receives: Device: Dynamic Navigation Assisted Implant Surgery |
| Freehand | Active comparator | Dental implant surgery via conventional freehand Receives: Procedure: Freehand Implant Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between the planned and placed implant positions
Deviations between the planned and placed implants will be measured by matching the pre- and post-op tomographic images.
Measured: 12 weeks
Secondary outcomes (1)
Damage to the surrounding critical anatomy
Any damage to the sinus maxillaries
Measured: 1 day (On the day of surgery).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start1 Jan 2014
- Primary completion1 Jan 2018
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental Implants, Surgery, ComputersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dental implant surgery assisted by a stereotaxic surgical instrument
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Arisan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471208
- Sponsor's protocol ID
- Navigation
- Status last verified
- Mar 2018
- First submitted
- 22 Feb 2018
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
PubMed 31829457
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand
- ClinicalTrials.gov ID
- NCT03471208
- Acronym / sponsor ID
- Navigation
- Conditions
- Dental Implants, Surgery, Computers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 20 Mar 2018 (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.
Placement of dental implants via the freehand approach may result in damage to the surrounding critical anatomy of undiscordant prosthetic position. A real-time navigational stereotaxic surgical instrument (navigation) may help to alleviate these undesired outcomes in the freehand approach.
All patients received implants in the right and left the side of their upper jaws via the random use of the navigation or the freehand approach. Positional deviations between the planned and placed implants were measured on a final tomographic image matched to the baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Dental implant surgery assisted by a stereotaxic surgical instrument
| Arm | Type | Receives |
|---|---|---|
| Dynamic Navigation | Experimental | Device: Dynamic Navigation Assisted Implant SurgeryDental implant surgery via dynamic navigation assistance |
| Freehand | Active comparator | Procedure: Freehand Implant SurgeryDental implant surgery via conventional freehand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- men and women aged >18 years.
- Patients approving to participate in the trial and giving written consent
- must be able to open his/her mouth
Key exclusion criteria (6 listed)
- Hemodynamically significant mitral valve stenosis
- Prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted)
- Planned cardioversion (electrical or pharmacological)
- Transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, pulmonary embolism, recent surgery, myocardial infacrtion)
- Known presence of atrial myxoma or left ventricular thrombus
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 Navigation Assisted Implant SurgeryImplant surgery using dynamic navigation assistance | Device | Dynamic Navigation |
| Freehand Implant SurgeryAlso: Dental implant surgery via conventional freehandDental implant surgery via conventional freehand | Procedure or surgery | Freehand |
Primary outcome
Change between the planned and placed implant positions
Time frame: 12 weeks
Deviations between the planned and placed implants will be measured by matching the pre- and post-op tomographic images.
1 secondary outcome
Damage to the surrounding critical anatomy
Time frame: 1 day (On the day of surgery).
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 21 Mar 2018.
- Derived from this study: PubMed 31829457Aydemir CA, Arisan V. Accuracy of dental implant placement via dynamic navigation or the freehand method: A split-mouth randomized controlled clinical trial. Clin Oral Implants Res. 2020 Mar;31(3):255-263. doi: 10.1111/clr.13563. Epub 2019 Dec 29.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Navigation Assisted Implant Surgery and Freehand Implant Surgery in people with Dental Implants, Surgery, Computers, run by Istanbul University.
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 3 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 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Change between the planned and placed implant positions (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471208, which also lists 1 linked publication.
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 21 Mar 2018.