Dynamic Navigation-Assisted Dental Implant Placement

Dental Implants, Surgery, Computers Clinical Trial

Official title:

Dynamic Navigation-Assisted Dental Implant Placement: A Randomised Controlled Clinical Trial Comparing Accuracy With the Freehand

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471208
• Other study ID #: Navigation
• Status: Completed
• Phase: N/A
• First received: February 22, 2018
• Last updated: March 19, 2018
• Start date: January 1, 2014
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2018
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Dental Implants, Surgery, Computers

Intervention

Device:
• Dynamic Navigation Assisted Implant Surgery
Implant surgery using dynamic navigation assistance

Procedure:
• Freehand Implant Surgery
Dental implant surgery via conventional freehand

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Damage to the surrounding critical anatomy	Any damage to the sinus maxillaries	1 day (On the day of surgery).