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NCT Number: NCT06865209

Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Odontolico de Bellvitge Universidad de Barcelona

Barcelona, 08907, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monolithic Zirconia Posterior Single Screw Retained Implant Crowns

Device

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

Primary outcomes

  1. Cost

    Time frame: 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

  2. Efficiency

    Time frame: 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 outcomes

  1. Functional Implant Prosthetic Score (FIPS)

    Time frame: 1 week post-op to 1 year follow up

    Analyze treatment quality outcomes according to the Functional Implant Prosthetic Score. Score 0-10

  2. Patient Related Outcome Measures (PROMs)

    Time frame: 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

  3. Accuracy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Registry information

Official study title

Monolithic Zirconia Posterior Single Crowns. a Time-Efficiency Study of a Complete Digital Flow: a Randomized Clinical Trial.

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.