Dynamic Navigation-Assisted Dental Implant Placement

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03471208

Enrollment

Registered

2018-03-20

Start date

2014-01-01

Completion date

2018-01-01

Last updated

2018-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Implants, Surgery, Computers

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.

Interventions

DEVICEDynamic Navigation Assisted Implant Surgery

Implant surgery using dynamic navigation assistance

PROCEDUREFreehand Implant Surgery

Dental implant surgery via conventional freehand

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Masking description

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

Intervention model description

Dental implant surgery assisted by a stereotaxic surgical instrument

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Change between the planned and placed implant positions	12 weeks	Deviations between the planned and placed implants will be measured by matching the pre- and post-op tomographic images.

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026