Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.

Not Applicable

Active, not recruiting

• Conditions: Posterior Single Edentulous Sites

• Registration Number: NCT06865209
• Lead Sponsor: University of Barcelona

Brief Summary

Monolithic Zirconia Posterior Single Crown cost-efficiency study. Objective and subjective analysis will be performed through FIPS and PROMs scales to evaluate treatment quality outcomes.

Detailed Description

Introduction Posterior implant single crowns have become the treatment of choice for single tooth replacement in the posterior sectors, due to its biological implications and minimally invasive approach since it requires no preparation of the adjacent tooth and enabling a more efficient hygiene for the patient than a bridge restoration. However, implant-based restorations require more time and economical resources from the patient and the dentist compared to traditional teeth-supported restorations.

Currently the main interest is set upon broadening the potential patient spectrum for this kind of therapies, which can only be achieved by significally reducing the clinical treatment time and technical production time while maintaining an acceptable profit ratio and good quality treatment outcome.

Objectives The main goal of this study is to determine whether monolithic screw retained posterior implant crowns (test) are more time-efficient than metal ceramic screw retained posterior implant. Moreover, as secondary objectives every screw retained crown will be submitted for Functional Implant Prosthodontic Score (FIPS) and Patient Related Outcome Measures (PROMs) evaluation. Hypothesis Monolithic screw-retained posterior single implant crowns performed through a full digital workflow are more time-efficient than conventional-digital workflow fabricated metal-porcelain screw-retained posterior single implant crowns.

Monolitihic single posterior screw-retained implant crowns achieve better quality outcomes than metal porcelain single posterior screw-retained implant crowns.

Material \& Methods A total of 40 implants placed at Master de Integrada de Adultos will participate in a time- efficiency study that will compare monolithic screw-retained posterior implant crowns to metal ceramic screw-retained posterior implant crowns ( gold standard), moreover, every restoration will be submitted for Functional Implant Prosthetic Score (FIPS) and Patient Related Outcome Measures (PROMs)

Study Timeline

• Study First Submitted: 2021-01-24
• Study Start: 2021-02-19
• Primary Completion: 2024-06-09
• Status Verified: 2025-02
• Study First Submitted QC: 2025-03-03
• Last Update Submitted: 2025-03-03
• Study First Posted: 2025-03-07
• Last Update Posted: 2025-03-07
• Study Completion: 2026-01-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Restorable implants
• No signs or previous history of periimplantitis
• Natural antagonist teeth
• Natural adjacent teeth

Exclusion Criteria

• Non restorable implants
• Signs or previous history of periimplantitis
• No natural antagonist teeth
• No natural adjacent teeth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cost	From the first visit to definitive crown placement	Analyze how many cost units (monetary unit) are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
Efficiency	From the first visit to definitive crown placement	Analyze how much time are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns

Secondary Outcome Measures

Name	Time	Method
Functional Implant Prosthetic Score (FIPS)	1 week post-op to 1 year follow up	Analyze treatment quality outcomes according to the Functional Implant Prosthetic Score. Score 0-10
Patient Related Outcome Measures (PROMs)	1 week post-op to 1 year follow up	Analyze how the patient perceives treatment outcomes according to the Patient Related Outcome Measures scale. Score 0-10
Accuracy	Prosthetic Baseline to Definitive Crown Placement	Analyze castless full digital workflow accuracy, comparing the matching accuracy of the definitive crowns to the digital wax up for both groups. Both STL meshes will be analyzed with Shape Designer by 3 Shape to asses how does the physical prostheses match the virtual wax ups

Trial Locations

Locations (1)

Hospital Odontolico de Bellvitge Universidad de Barcelona; 🇪🇸 Barcelona, Spain