跳至主要内容
临床试验/NCT06865209
NCT06865209进行中(未招募)不适用

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

University of Barcelona1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年2月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
50
试验地点
1
主要终点
Cost

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

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

排除标准

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

研究组 & 干预措施

Direct Finish Single Posterior Monolithic Zirconia Screw Retained Implant Crowns

Experimental

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

干预措施: Monolithic Zirconia Posterior Single Screw Retained Implant Crowns (Device)

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

Active Comparator

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

干预措施: Monolithic Zirconia Posterior Single Screw Retained Implant Crowns (Device)

结局指标

主要结局

Cost

时间窗: 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

时间窗: 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

次要结局

  • Functional Implant Prosthetic Score (FIPS)(1 week post-op to 1 year follow up)
  • Patient Related Outcome Measures (PROMs)(1 week post-op to 1 year follow up)
  • Accuracy(Prosthetic Baseline to Definitive Crown Placement)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guillermo Galván Lobo

Principal Investigator

University of Barcelona

研究点 (1)

Loading locations...

相似试验

Monolithic Zirconia Posterior Single Crowns: a... | 临床试验