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

January 8, 2026 updated by: Miguel Gómez Polo, Universidad Complutense de Madrid

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Computer-guided implant surgery has consolidated a prosthetically driven approach, in which implant positioning is planned according to the definitive or provisional restoration. The integration of cone-beam computed tomography (CBCT) and intraoral scanning allows for virtual planning of implant position, axis, and prosthetic emergence. However, the accurate transfer of the digital plan to the clinical setting remains subject to cumulative errors throughout the digital and surgical workflow.

Accuracy in guided implant surgery is commonly assessed by comparing the planned and postoperative implant positions using linear and angular deviation metrics. From a clinical perspective, the accuracy at the level of the provisional restoration is of particular relevance, as the restoration must seat passively without requiring significant adjustment. This requirement becomes especially critical when an immediate prefabricated screw-retained provisional crown is placed at the time of surgery, as both positional and rotational accuracy are essential for proper seating.

Recent digital workflows have demonstrated the feasibility of designing and fabricating immediate provisional restorations prior to surgery. The use of guided surgical protocols incorporating rotational control aims to reproduce the planned implant orientation and facilitate the immediate placement of prefabricated restorations. However, the accuracy achievable with such workflows has not been sufficiently quantified in clinical settings.

Justification Despite advances in guided surgery and digital manufacturing, limited clinical evidence exists regarding the accuracy of workflows that combine fully guided implant placement with rotational control and the immediate placement of a prefabricated screw-retained provisional crown. Quantifying plan-to-actual deviations at both the implant and restoration levels is essential to determine the clinical feasibility, predictability, and potential optimization of this protocol.

Study Design This is a prospective, single-arm interventional clinical trial with an intraindividual comparison between the digitally planned implant and provisional restoration positions and the actual clinical outcomes obtained after guided surgery.

Participants The study population will consist of partially edentulous patients aged 18 years or older who require the replacement of a single tooth with an immediately loaded dental implant. All participants must meet the predefined inclusion criteria and none of the exclusion criteria and must provide written informed consent prior to participation.

Intervention All participants will undergo a fully digital workflow including CBCT acquisition, intraoral scanning, virtual implant planning, and the design and fabrication of a surgical guide and a prefabricated screw-retained provisional crown. Implant placement will be performed using a fully guided surgical protocol with rotational control. The provisional restoration will be placed immediately after implant insertion and kept free of occlusal contacts.

Outcome Assessment Postoperative intraoral scans will be obtained with a scan body and with the provisional restoration in place. Three-dimensional analysis software will be used to compare the planned and achieved positions. Linear and angular deviations at the coronal and apical implant levels, as well as deviations of the provisional restoration, will be calculated to assess accuracy in terms of trueness and precision.

Statistical Analysis Descriptive statistics will be used to summarize the deviation measurements. Normality will be assessed, and appropriate parametric or non-parametric tests will be applied to determine whether the observed deviations differ significantly from clinically acceptable thresholds.

Study Type

Interventional

Enrollment (Estimated)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Miguel A Gómez Polo ; DDS, PhD, DDS, PhD
  • Phone Number: +34659390001
  • Email: mgomezpo@ucm.es

Study Contact Backup

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28040
        • Recruiting
        • Complutense University of Madrid
        • Contact:
        • Sub-Investigator:
          • Solange J Vasquez Ramos, DDS, MSc
        • Sub-Investigator:
          • Juan Ballesteros Martinez, DDS, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Adults aged 18 years or older.
  2. Partially edentulous patients requiring replacement of a single tooth with an immediately loaded dental implant.
  3. Patients classified as ASA I or ASA II according to the American Society of Anesthesiologists physical status classification.
  4. Patients with clinical conditions allowing immediate implant placement with a minimum primary stability of ≥25 Ncm.
  5. Ability to understand the study procedures and provide written informed consent.
  6. Willingness to comply with the study protocol and attend required clinical visits.

Exclusion Criteria:

  1. Patients classified as ASA III or ASA IV, or with uncontrolled systemic conditions that may interfere with study participation.
  2. Presence of psychiatric or cognitive disorders that may compromise informed consent or protocol compliance.
  3. Inability to comply with the visit schedule or required evaluations.
  4. Any other condition that, in the investigator's judgment, could compromise patient safety, protocol adherence, or data validity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fully Guided Implant Surgery With Immediate Prefabricated Provisional Crown
Participants will undergo a fully guided implant placement procedure with rotational control, followed by the immediate placement of a previously fabricated screw-retained provisional crown designed during the digital planning phase.
Procedure: Fully Guided Implant Placement and Immediate Provisionalization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Implant and Provisional Crown Placement
Time Frame: Immediate postoperative period
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.
Immediate postoperative period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Investigators

  • Principal Investigator: Miguel A Gómez Polo, DDS, PhD, Universidad Complutense de Madrid
  • Principal Investigator: Juan Ballesteros- Martinez, DDs, MSc, Universidad Complutense de Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

January 8, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25/700-E

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and privacy considerations. The data collected include detailed clinical and radiographic information that could potentially allow re-identification of participants, even after de-identification. Data will be used solely for the purposes defined in the approved study protocol.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Partial Edentulism

Clinical Trials on Fully Guided Implant Placement and Immediate Provisionalization

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe