In Vivo Evaluation of the Accuracy of Immediate Screw-Retained Provisional Crowns Fabricated Using Digital Planning and Guided Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad Complutense de Madrid

About this trial

This clinical trial aims to evaluate the in vivo accuracy of a fully digital workflow for the immediate placement of a previously fabricated screw-retained provisional crown using digital planning and guided implant surgery. The study will be conducted in partially edentulous adult patients requiring the replacement of a single tooth with an immediately loaded dental implant.

The main objective of the study is to assess the accuracy (trueness and precision) of the planned digital implant position and provisional restoration by comparing the virtually planned position with the actual clinical outcome after guided surgery. Emphasis will be placed on linear, angular, and rotational deviations at both the implant and provisional restoration levels.

Participants will undergo a fully guided implant placement procedure with rotational control, followed by the immediate placement of a prefabricated screw-retained provisional crown designed during the digital planning phase. Postoperative intraoral scans will be obtained to register the final implant and restoration positions.

The planned and achieved positions will be compared using three-dimensional analysis software to quantify deviations and determine whether the accuracy achieved remains within clinically acceptable limits.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged 18 years or older.

Partially edentulous patients requiring replacement of a single tooth with an immediately loaded dental implant.

Patients classified as ASA I or ASA II according to the American Society of Anesthesiologists physical status classification.

Patients with clinical conditions allowing immediate implant placement with a minimum primary stability of ≥25 Ncm.

Disqualifiers

Patients classified as ASA III or ASA IV, or with uncontrolled systemic conditions that may interfere with study participation.

Presence of psychiatric or cognitive disorders that may compromise informed consent or protocol compliance.

Inability to comply with the visit schedule or required evaluations.

Any other condition that, in the investigator's judgment, could compromise patient safety, protocol adherence, or data validity.

Trial design

Design model

Single group

Treatments tested in this trial

  • Fully Guided Implant Placement and Immediate Provisionalization

    Procedure/Surgery

    Fully guided implant placement using a digitally designed surgical guide with rotational control, followed by immediate placement of a prefabricated screw-retained provisional crown based on the virtual treatment plan.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Fully Guided Implant Surgery With Immediate Prefabricated Provisional CrownExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of Implant and Provisional Crown Placement

Accuracy will be assessed as the combination of trueness and precision by quantifying plan-to-actual deviations between the digitally planned and clinically achieved implant position and provisional crown position. Linear deviations at the coronal and apical implant levels, angular deviation of the implant axis, and linear and angular deviations of the provisional restoration will be calculated using three-dimensional analysis software.

Time frame
Immediate postoperative period

Secondary outcomes

Other outcomes

Sponsors and contacts

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