Dynamic Navigation-Assisted Dental Implant Placement

NCT ID: NCT03471208

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Implants, Surgery, Computers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Dental implant surgery assisted by a stereotaxic surgical instrument
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Investigation of the post-op images included anonymized patient names providing unbiased analysis.

Study Groups

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Dynamic Navigation

Dental implant surgery via dynamic navigation assistance

Group Type EXPERIMENTAL

Dynamic Navigation Assisted Implant Surgery

Intervention Type DEVICE

Implant surgery using dynamic navigation assistance

Freehand

Dental implant surgery via conventional freehand

Group Type ACTIVE_COMPARATOR

Freehand Implant Surgery

Intervention Type PROCEDURE

Dental implant surgery via conventional freehand

Interventions

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Dynamic Navigation Assisted Implant Surgery

Implant surgery using dynamic navigation assistance

Intervention Type DEVICE

Freehand Implant Surgery

Dental implant surgery via conventional freehand

Intervention Type PROCEDURE

Other Intervention Names

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Dental implant surgery via conventional freehand

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Volkan Arisan

Dr. Volkan Arısan

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31829457 (View on PubMed)

Other Identifiers

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Navigation

Identifier Type: -

Identifier Source: org_study_id

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