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CompletedNCT03764176Updated Jul 13, 2026

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

An interventional study of Conventional impressions and Digital impressions in Dental Implant Failure, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by University of Valencia · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2018, registered Nov 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dental Implant Failure
03

In context

Lead sponsor

University of Valencia is the lead sponsor of 349 studies on the registry; 73 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Conventional impression

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

    Procedure: Conventional impressions

  • Experimental
    Digital impression

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

    Procedure: Digital impressions

Interventions

  • ProcedureConventional impressions

    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.

  • ProcedureDigital impressions

    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.

06

What researchers measure

Primary outcomes

  1. Linear distance between planned and real implant apex position

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

    Time frame: Immediate post-surgery

  2. Angle between the planned and real implant axis

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

    Time frame: Immediate post-surgery

07

Study locations

1 site
  • Clínica Odontológica de la Universitat de Valencia, Fundación Lluis Alcanyis
    Valencia, 46010, Spain
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03764176
Lead sponsor
University of Valencia
Responsible party
David Peñarrocha Oltra (Assistant Postdoctoral Lecturer (Profesor Ayudante Doctor), University of Valencia) — Principal investigator
First posted
Dec 4, 2018
Start date
Jan 8, 2018
Primary completion
Jul 31, 2019
Completion
Dec 31, 2019
Last update
Jul 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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