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Clinical Trials/NCT03764176
NCT03764176
Unknown
N/A

Accuracy of Computer-assisted Template-based Implant Placement Using Conventional Impression and Scan Model or Digital Impression: a Randomized Controlled Trial

University of Valencia1 site in 1 country40 target enrollmentJanuary 8, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Dental Implant Failure
Sponsor
University of Valencia
Enrollment
40
Locations
1
Primary Endpoint
Angle between the planned and real implant axis
Last Updated
7 years ago

Overview

Brief Summary

Proper implant position has a significant impact in esthetic and functional outcomes of implant-supported restorations. Computer-assisted template-based implant placement (guided surgery) have become increasingly popular due to improved planning and the higher transfer accuracy of the virtual plan to the surgical site compared with freehand insertion or freehand final drilling. Digital impressions replace the need for traditional materials that can be inconvenient and messy for patients. To the best of our knowledge, at the time of planning this study, there were no published RCTs evaluating a fully digital approach for computer-assisted template-based implant placement.

The aim of the present study is to compare early implant failure, template-related complications, and virtual planning accuracy of computer-assisted template-based implant placement using conventional impression and scan model or digital impression.

The null hypothesis is that there will be no difference between these interventions.

Registry
clinicaltrials.gov
Start Date
January 8, 2018
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Peñarrocha Oltra

Assistant Postdoctoral Lecturer (Profesor Ayudante Doctor)

University of Valencia

Eligibility Criteria

Inclusion Criteria

  • fully or partially edentulous patient, aged 18 years or older, able to sign an informed consent, in need of an implant-supported fixed restoration will be considered eligible for this study. Any potential implant locations based on individual patient requirements will be considered eligible in the present trial. No set location or group of locations will be excluded.

Exclusion Criteria

  • general medical contraindication to oral surgery (American Society of Anesthesiologist, ASA, class III or IV); irradiation in the head and neck area less than one year before implantation; psychiatric problems; alcohol or drug abuse; pregnant or nursing; untreated periodontitis; severe bruxism or clenching; uncontrolled diabetes; poor oral hygiene and motivation; and inability to complete the follow-up.

Outcomes

Primary Outcomes

Angle between the planned and real implant axis

Time Frame: Immediate post-surgery

Change in angulation between the planned and the final (real) position of the implant.

Linear distance between planned and real implant apex position

Time Frame: Immediate post-surgery

The change in mm between the apex of the planned and the final (real) position of the implant.

Study Sites (1)

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