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

University of Valencia

Status: Unknown

Conditions: Dental Implant Failure

Treatments: Procedure: Digital impressions; Procedure: Conventional impressions

Study type: Interventional

Funder types: Other

Identifiers

NCT03764176

H1497613138277

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Conventional impression

Active Comparator group

Description:

The intervention of this arm will be "conventional impression": polyether impression will be taken with a customized tray.

Treatment:

Procedure: Conventional impressions

Digital impression

Experimental group

Description:

The intervention of this arm will be "digital impression": digital impression will be taken using a CS 3600 intraoral scanner .

Treatment:

Procedure: Digital impressions