Accuracy of Computer-assisted Template-based Implant Placement Using Conventional or Digital Impression

Not Applicable

• Conditions: Dental Implant Failure
• Interventions: Procedure: Conventional impressions; Procedure: Digital impressions

• Registration Number: NCT03764176
• Lead Sponsor: University of Valencia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Study First Submitted: 2018-11-27
• Status Verified: 2018-12
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Last Update Submitted: 2018-12-04
• Last Update Posted: 2018-12-06
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional impression	Conventional impressions	The intervention of this arm will be "conventional impression": polyether impression will be taken with a customized tray.
Digital impression	Digital impressions	The intervention of this arm will be "digital impression": digital impression will be taken using a CS 3600 intraoral scanner .

Primary Outcome Measures

Name	Time	Method
Angle between the planned and real implant axis	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	Immediate post-surgery	The change in mm between the apex of the planned and the final (real) position of the implant.

Trial Locations

Locations (1)

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis; 🇪🇸 Valencia, Spain