Accuracy of pre-made screw-retained temporary crowns placed with digital planning and guided implant surgery

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

This project will test whether a fully digital planning and guided surgery workflow lets pre-made screw-retained temporary crowns seat accurately for adults needing a single immediate dental implant.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Universidad Complutense de Madrid (other)
• Locations: 1 site (Madrid, Madrid)
• Trial ID: NCT07315607 on ClinicalTrials.gov

What this trial studies

Eligible adults will receive CBCT and intraoral scans to create a virtual implant and restoration plan and to fabricate a prefabricated screw-retained provisional crown. A fully guided implant placement with rotational control will be performed and the prefabricated provisional will be placed immediately after implant insertion. The planned digital positions will be compared with postoperative clinical outcomes using linear, angular, and rotational deviation measures to determine trueness and precision. The primary practical outcome is whether the provisional restoration seats passively without significant adjustment.

Who should consider this trial

Good fit: Adults (18+) with partial tooth loss who need a single tooth replaced with an immediately loaded implant, are ASA I–II, can achieve primary stability ≥25 Ncm, and can provide informed consent.

Not a fit: Patients with multiple missing teeth, poor bone quality or insufficient primary stability, uncontrolled systemic disease (ASA III–IV), or those unable to attend the Madrid site are unlikely to benefit.

Why it matters

Potential benefit: If successful, patients could receive immediate, well-fitting temporary crowns made before surgery, reducing chair time and the need for on-the-spot adjustments.

How similar studies have performed: Prior studies show guided implant surgery and prefabricated provisional restorations are feasible but accuracy results vary, and a fully digital workflow with rotational control is relatively novel.

Eligibility criteria

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.

Where this trial is running

Madrid, Madrid

• Complutense University of Madrid — Madrid, Madrid, Spain (RECRUITING)

Study contacts

• Principal investigator: Miguel A Gómez Polo, DDS, PhD — Universidad Complutense de Madrid
• Study coordinator: Miguel A Gómez Polo ; DDS, PhD, DDS, PhD

Conditions: Partial Edentulism, Tooth Loss / Rehabilitation, Immediate provisionalization, Screw-retained provisional crown, Guided implant surgery, Digital implant planning