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临床试验/NCT06052501
NCT06052501招募中不适用

3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations

Implantology Institute1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Volumetric changes in peri-oral area

研究概览

简要总结

The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient.

The use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.

详细描述

Digital technologies have evolved exponentially in the dental medicine field endorsing a change between the conventional methods to virtually based methodologies in daily clinical and laboratorial practice.

Combining facial aspects and proportions with dento-gingival parameters are the basis when planning a new smile design and a final rehabilitationFacial surface images can be used for more predictable measurement and quantification of vertical dimension of occlusion and lip support before, during and after a full mouth rehabilitation. Besides that, the information obtained by facial scanners have a major impact in treatment planning process especially in multidisciplinary complex cases with the simulation of the treatment, identification of patient's expectations and the implementation of an effective communication tool.

The 4D-virtual patient is the future regarding the management of a patient in dental medicine, since the beginning of the process with data acquisition for the diagnosis to the definitive oral rehabilitation procedures. Similar to any methodology, it is important to understand what are the basis of the facial scanning and what protocols can obtain better results in terms of accuracy and reliability.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Individuals with at least a full-arch implant supported rehabilitation in the upper arch
  • Individuals with a provisional or a definitive implant-supported prosthesis
  • Individuals with a stable occlusion function
  • Individuals with compliance to collaborate with the research protocol

排除标准

  • Individuals with history of hypersensitivity to external light or any similar condition
  • Individuals in an active surgical treatment period
  • Individuals in an active orthodontic treatment in the opposite arch
  • Individuals in an active facial treatment
  • Individuals who did not attend the maintenance visits

结局指标

主要结局

Volumetric changes in peri-oral area

时间窗: same day

The primary outcome is to evaluate the changes in volume in peri-oral area after removal a full arch implant-supported prostheses according to a digital analysis (RMS)

次要结局

  • Distance between the upper lip and E-line in sagital profile(same day)
  • Distance between the lower lip and E-line in sagital profile(same day)
  • Naso-labial angle(same day)

研究者

发起方
Implantology Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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