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临床试验/NCT07105995
NCT07105995招募中不适用

Effects of Test Foods of Different Hardness and Size on Mandibular Movements and Occlusal Morphology.

Istanbul University2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
24
试验地点
2
主要终点
Linear deviation of reference points on occlusal morphology

研究概览

简要总结

One of the most important goals of prosthetic treatment is to make the occlusal morphology suitable for the patient's original anatomy. Mechanical articulators are metal devices that mimic the temporomandibular joint and lower jaw movements, and attempts have been made to make them patient-specific over the years. For this purpose, semi-adjustable articulators were first developed. Later, fully adjustable articulators were introduced to the market. Although these devices have the closest imitation mechanism to the patient's original anatomy, they have various limitations. Adjusting mechanical articulators and recording lower jaw movements have been researched in dentistry clinics and dentistry literature for many years. Due to the limitations of articulators, digital recordings of lower jaw movements have been started since 1989. Later, in 2002, the process of adjusting virtual articulators in a computer environment according to the digital recording data of the mandibular movements was started. In this way, the limitations of mechanical articulators such as metal deformation, difficulties experienced during recording, distortion of plaster and recording material, insufficient stability, adaptation problems of base plates, logistic problems between the laboratory and the physician, and inability to store data have been largely eliminated. In addition, mechanical articulators still cannot fully mimic the anatomy of the temporomandibular joint and related muscles. Digital recording of mandibular movements and transferring them to a virtual environment were first tried with electronic methods, and these systems were developed and ultrasonic and optoelectronic methods were used. Today, tooth movement records can be obtained with 3D video motion analysis methods. By superimposing these data with the data of digital models of the jaws, a mandibular movement recording method has been developed that can now produce restorations without the need for virtual or mechanical articulators. All these developments arise from the desire to record more appropriate and adaptable mandibular movement patterns, overcoming the difficulties in imitating complex patterns of mandibular movements that vary from the size, initial height and consistency of the food to the patient's mental state during the mandibular chewing movement. Thus, we will be able to obtain the most appropriate occlusal morphology for the patient to chew at maximum performance in the prosthetic or restorative procedures we will perform. With the developing technology, mandibular movement recordings can be recorded not only in the border movements as in the past, but also during chewing. In the literature, the majority of studies conducted by having the patient chew a test food are studies measuring the activity of the masticatory muscles, the distance between the incisors, the lateral movement distance or the magnitude of the chewing stroke.

For this reason, in this study, mandibular movements will be recorded with optical motion tracking systems and 4-unit fixed partial dentures(FPDs) for teeth 4.4 - 4.7 will be designed according the recordings.

The study will include individuals who are in the molar class 1 of the Angle classification, who have no temporomandibular joint and masticatory muscle disorders, who have no missing or extra teeth, who have no fillings or crowns on teeth numbered 4.4-4.7, who have not undergone orthodontics, and who are not allergic to the test foods. The subjects will sign a consent form. After the subjects are examined, lower and upper jaw scans and bite scans will be recorded. In the 2nd session, facebow records, border movements and chewing records with 5 different test foods will be recorded from the subjects with an optical lower jaw movement tracker(Zebris JMA Optic). These test foods were selected according to the literature and are cheese, raw carrots, boiled carrots, crispy bread and pre-polymerized silicone impression material. After recordings, fixed partial dentures will be designed via virtual articulator, border movement recordings and for 5 different foods in digital design program. 7 different FDPs designs for each subject will be overlapped with the subject's original anatomy in the Geomagic program.

详细描述

A fundamental objective in prosthodontic rehabilitation is the accurate replication of the patient's native occlusal architecture. Since the early 20th century, dentistry has endeavored to simulate the functional dynamics of the temporomandibular joint (TMJ) and mandibular motion through the use of mechanical articulators-metallic devices engineered to replicate mandibular kinematics. Over time, these articulators have evolved from basic models to more sophisticated, patient-specific systems. Initially, semi-adjustable articulators emerged, followed by the development of fully adjustable variants intended to more closely approximate individual anatomical parameters. Despite their improved accuracy, these devices are not without limitations.

While fully adjustable articulators represent the most anatomically faithful mechanical approximation of mandibular function, they remain inherently limited in precision and adaptability. The calibration of these devices and the accurate documentation of mandibular movements have been subjects of long-standing investigation within both clinical and academic domains of dentistry. In response to the intrinsic shortcomings of mechanical systems-such as susceptibility to material deformation and challenges in capturing dynamic motion-digital motion capture technologies began to emerge in 1989. This transition marked a significant shift toward enhancing the fidelity of mandibular movement analysis.

By 2002, advancements in digital dentistry enabled the integration of virtual articulators within computer-aided design environments, utilizing digitally captured mandibular movement data. This innovation substantially addressed the limitations associated with traditional mechanical articulators, including structural deformation, inaccuracies during physical registration, degradation of plaster or recording media, and logistical inefficiencies in transferring physical components between clinical and laboratory settings. Furthermore, digital systems introduced the critical advantage of data preservation and reproducibility-parameters difficult to achieve with analog models.

Despite ongoing enhancements, mechanical articulators remain incapable of fully replicating the complex anatomical and neuromuscular intricacies of the temporomandibular joint and its associated musculature. Initial efforts to digitally capture mandibular motion involved rudimentary electronic methodologies, which were subsequently refined through the application of ultrasonic and optoelectronic tracking technologies. These innovations significantly improved the spatial resolution and reliability of movement data, enabling more sophisticated integration with virtual modeling systems.

Contemporary techniques now permit the acquisition of mandibular motion data through three-dimensional video-based motion capture systems. When these dynamic recordings are overlaid onto digitized jaw models, a new paradigm in prosthetic design is achieved-allowing for the fabrication of dental restorations without reliance on either virtual or physical articulators. This method not only enhances anatomical precision but also minimizes procedural constraints associated with traditional systems.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • having Angle molar class 1 occlusion
  • over 18 years old
  • not undergone any orthodontic treatment
  • not having any temporomandibular or masticatory disorders
  • not having any pain or sensitivity on temporomandibular joint, masticatory muscle
  • not having missing teeth or implant-supported restorations
  • not having fillings or crowns on teeth 4.4 - 4.7
  • not having supernumerary teeth
  • not allergic to test foods
  • volunteering to participate
  • being a student at Istanbul University Faculty of Dentistry

排除标准

  • not having Angle molar class 1 occlusion
  • under 18 years old
  • undergone any orthodontic treatment
  • having any temporomandibular or masticatory disorders
  • having any pain or sensitivity on temporomandibular joint, masticatory muscle
  • having missing teeth or implant-supported restorations
  • having fillings or crowns on teeth 4.4 - 4.7
  • having supernumerary teeth
  • allergic to test foods
  • not volunteering to participate
  • not being a student at Istanbul University Faculty of Dentistry

结局指标

主要结局

Linear deviation of reference points on occlusal morphology

时间窗: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.

Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for linear deviations measured in micrometers.

Angular deviation of reference points on designed occlusal morphology

时间窗: From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.

Following the superimposition of the designed occlusal morphologies onto the participants' original occlusal anatomy, thirteen reference points will be assessed for angular deviations measured in micrometers."

次要结局

  • Chewing cycles amplitude(From enrollment to data collection at 12 weeks. After data collection participants do not take place on designing and analyzing phases.)
  • Chewing cycles width(From enrollment to data collection at 12 weeks. Occlusal morphology designs will be held on design program after data collection. Participiants do not take place at this phase of the study.)

研究者

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

Ayşenur Özcan-Sezgin

Principal Investigator

Istanbul University

研究点 (2)

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