Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.

NCT ID: NCT06865209

Last Updated: 2025-03-07

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-19
• Study Completion Date: 2026-01-09

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)

Conditions

Posterior Single Edentulous Sites

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Direct Finish Single Posterior Monolithic Zirconia Screw Retained Implant Crowns

Direct finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol.

Group Type: EXPERIMENTAL

Monolithic Zirconia Posterior Single Screw Retained Implant Crowns

Intervention Type: DEVICE

Posterior single edentulous sites will be rehabilitated with monolithic zirconia single posterior implant crowns following two different full digital workflows

3d Prototype Guided Single Posterior Monolithic Zirconia Screw Retained Implant Crowns

Direct finish single posterior monolithic zirconia screw retained implant crowns, performed with full digital flow direct finish prosthetic protocol.

Group Type: ACTIVE_COMPARATOR

Monolithic Zirconia Posterior Single Screw Retained Implant Crowns

Intervention Type: DEVICE

Posterior single edentulous sites will be rehabilitated with monolithic zirconia single posterior implant crowns following two different full digital workflows

Interventions

Monolithic Zirconia Posterior Single Screw Retained Implant Crowns

Posterior single edentulous sites will be rehabilitated with monolithic zirconia single posterior implant crowns following two different full digital workflows

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Guillermo Galván Lobo

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Odontolico de Bellvitge Universidad de Barcelona

Barcelona, Barcelona, Spain

Countries

Spain

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Other Identifiers

33/2020

Identifier Type: -

Identifier Source: org_study_id