Dynamic Navigation-Assisted Dental Implant Placement

March 19, 2018 updated by: Volkan Arisan, Istanbul University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic Navigation
Dental implant surgery via dynamic navigation assistance
Device: Dynamic Navigation Assisted Implant Surgery
Implant surgery using dynamic navigation assistance
Active Comparator: Freehand
Dental implant surgery via conventional freehand
Procedure: Freehand Implant Surgery
Dental implant surgery via conventional freehand
Other Names:
  • Dental implant surgery via conventional freehand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Damage to the surrounding critical anatomy
Time Frame: 1 day (On the day of surgery).
Any damage to the sinus maxillaries
1 day (On the day of surgery).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

February 22, 2018

First Submitted That Met QC Criteria

March 13, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2018

Last Update Submitted That Met QC Criteria

March 19, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • Navigation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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