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Recruiting Not applicable

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

NCT07315607 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2026-01
Last updated
2026-01-09

Condition(s) studied

Partial EdentulismTooth Loss / Rehabilitation

Investigational drug(s) / intervention(s)

Fully Guided Implant Placement and Immediate Provisionalization

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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Accuracy of Implant and Provisional Crown Placement — 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.

Trial sites (1)

FacilityCityRegionStatus
Complutense University of Madrid Madrid Madrid Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07315607 on ClinicalTrials.gov ↗ ← All trials in Spain