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Completed

NCT Number: NCT03764176

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

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.

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Key information

Conditions

Dental Implant Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis

Valencia, 46010, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Conventional Impressions

Procedure

In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.

A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery.

Digital impressions

Procedure

Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.

A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2018
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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