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临床试验/NCT07016048
NCT07016048尚未招募不适用

Facial Scanning and Computerized Tomography as Aids in Single-tooth Rehabilitation Planning

Egas Moniz - Cooperativa de Ensino Superior, CRL0 个研究点目标入组 25 人开始时间: 2025年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
25
主要终点
Differences before and after occlusal adjustments

研究概览

简要总结

The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown.

After collecting the patients, at the first appointment, data collection will be carried out, including: an intraoral scan (digital impressions), intraoral and extraoral photographs, CBCT, and facial scanning.

At the following appointment, a mock-up will be performed. The purpose of the mock-up is to preview the expected smile outcome before beginning the oral rehabilitation treatment.

After each mock-up, patients will be asked to complete a questionnaire designed to evaluate their self-perception of comfort and aesthetics.

Additionally, after each mock-up, the clinician will assess occlusal contacts (the bite) and record the time required for adjustments to achieve a comfortable occlusion for the patient.

The main questions it aims to answer are:

  • How does the patient perceive comfort and aesthetics during the rehabilitation process?
  • What is the influence of using a virtual articulator on diagnostic waxing accuracy?
  • How does integrating facial scanning (FS) and cone-beam computed tomography (CBCT) affect current digital workflows involving a virtual articulator?
  • What impact does the programming of the virtual articulator have on treatment planning outcomes?

详细描述

The goal of this clinical trial is to evaluate the influence of Facial Scan (FS) and cone beam computed tomography (CBCT) in the prosthodontic treatment planning in patients who require rehabilitation with a single crown, with aims:

i) assessing patient's comfort and aesthetics self-perception; ii) evaluate the influence of a virtual articulator in a diagnostic waxing; iii) evaluate the influence of implementation of FS and CBCT to the current digital procedure with a virtual articulator; iv) evaluate the influence of programming the virtual articulator.

Data collection will be carried out in participants, including: an intraoral scan (digital impressions), intraoral and extraoral photographs (DPhotos), CBCT, and facial scan.

In a CAD/CAM software, we will integrate IOS, CBCT, and FS data into the virtual environment, and it will be possible the articulation of virtual models.

The digital wax-up for the preparation of the crown will be designed by the prosthodontist and then adjusted based on the occlusion obtained in each of the groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients who require rehabilitation with a single crown;
  • •The tooth to be rehabilitated must have an opponent to test the occlusion.

排除标准

  • •The tooth to be rehabilitated must does not have an opponent to test the occlusion;
  • •Edentulous patient;
  • •Incapable of understanding and/or giving consent.

研究组 & 干预措施

Static occlusion

Placebo Comparator

Use IOS + DPhotos - Set up the models and do a diagnostic waxing done only with static occlusion, without a virtual articulator (as the laboratories commonly do).

干预措施: Try-in of one crown test with a digital wax-up (per group) (Procedure)

Virtual articulator (standard values)

Active Comparator

Use IOS + DPhotos - Set up the models do a diagnostic waxing in the virtual articulator arbitrarily (without CBCT and FS) - with the program's default and standard values.

干预措施: Try-in of one crown test with a digital wax-up (per group) (Procedure)

Virtual articulator with CBCT and FS (standard values)

Active Comparator

Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the program's default and standard values.

干预措施: Try-in of one crown test with a digital wax-up (per group) (Procedure)

Programmed virtual articulator

Active Comparator

Use IOS + DPhotos + CBCT + FS - Set up the models and do a diagnostic waxing in the virtual articulator (with CBCT and FS) - with the articulator programmed for the patient - through dynamic scans.

干预措施: Try-in of one crown test with a digital wax-up (per group) (Procedure)

结局指标

主要结局

Differences before and after occlusal adjustments

时间窗: From enrollment to the end of treatment (8 weeks)

The primary outcome is the volumetric difference (in micrometers) before and after occlusal adjustments, in each group.

次要结局

  • Patients's aesthetics and comfort self-perception(From enrollment to the end of treatment (8 weeks))

研究者

发起方
Egas Moniz - Cooperativa de Ensino Superior, CRL
申办方类型
Other
责任方
Sponsor

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