Dynamic Navigation-Assisted Dental Implant Placement

NCT03471208 | Completed FDA Device

• 1 other identifier: Navigation
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (1)

• Damage to the surrounding critical anatomy

  1 day (On the day of surgery).

Study Arms (2)

Dynamic Navigation

EXPERIMENTAL

Dental implant surgery via dynamic navigation assistance

Device: Dynamic Navigation Assisted Implant Surgery

Freehand

ACTIVE COMPARATOR

Dental implant surgery via conventional freehand

Procedure: Freehand Implant Surgery

Interventions

Dynamic Navigation Assisted Implant Surgery DEVICE

Implant surgery using dynamic navigation assistance

Dynamic Navigation

Freehand Implant Surgery PROCEDURE

Dental implant surgery via conventional freehand

Also known as: Dental implant surgery via conventional freehand

Freehand

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Related Publications (1)

• 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.

  PMID: 31829457 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigation of the post-op images included anonymized patient names providing unbiased analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Volkan Arısan

Model Details: Dental implant surgery assisted by a stereotaxic surgical instrument

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 20, 2018
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 21, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share