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Monolithic Zirconia Posterior Single Crowns: a Randomized Clinical Trial.

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06865209
Enrollment
50
Registered
2025-03-07
Start date
2021-02-19
Completion date
2026-01-09
Last updated
2025-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Single Edentulous Sites

Keywords

Single Posterior Implant Crowns, Cost Efficiency, Monolithic Zirconia Crowns, Full Digital Workflow, 3D Printed Prototype

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)

Interventions

DEVICEMonolithic 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

Sponsors

University of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

The patient, the care provider and the principal investigator will be masked through the entire process

Intervention model description

Cost-efficiency study parallel study following CONSORT requisites

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CostFrom the first visit to definitive crown placementAnalyze how many cost units (monetary unit) are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns
EfficiencyFrom the first visit to definitive crown placementAnalyze how much time are needed to make monolithic zirconia single posterior implant supported crowns to assess economic profitability of theses crowns

Secondary

MeasureTime frameDescription
Functional Implant Prosthetic Score (FIPS)1 week post-op to 1 year follow upAnalyze 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 upAnalyze how the patient perceives treatment outcomes according to the Patient Related Outcome Measures scale. Score 0-10
AccuracyProsthetic Baseline to Definitive Crown PlacementAnalyze 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026