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临床试验/NCT07356622
NCT07356622已完成不适用

The Assessment of The Volumetric Occlusal Adjustments Required for Michigan Splints Fabricated Using Various Digital Bite Registrations

King's College London1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Volumetric occlusal adjustment of michigan occlusal splints

研究概览

简要总结

This clinical study evaluated digital occlusal recording methods used in the fabrication of Michigan occlusal splints. The objective was to assess whether different digital bite registration techniques influenced the accuracy of occlusal splints and the amount of occlusal adjustment required at clinical fitting.

Participants underwent digital bite registration procedures and received Michigan occlusal splints fabricated using different digital workflows. Follow-up visits were conducted for splint fitting and occlusal assessment. Participant safety and data confidentiality were maintained throughout the study, and all required ethical approvals and risk assessments were obtained prior to study initiation.

The study findings were intended to support improvements in digital dental workflows and enhance the accuracy and efficiency of occlusal splint fabrication.

详细描述

Background Temporomandibular disorders represented a common clinical condition affecting mandibular function and were frequently associated with parafunctional activities such as bruxism or clenching. Clinical features included orofacial pain, joint sounds, restricted mandibular movement, headaches, dental wear, and occlusal instability. Occlusal splints were commonly prescribed to reduce occlusal loading, protect dental structures, and establish a more favourable mandibular position.

Conventional occlusal splint fabrication relied on physical impressions, mechanical articulation, and manual occlusal adjustment. These processes were time-consuming and technique-sensitive. Digital dentistry introduced alternative workflows incorporating intraoral scanning, virtual articulation, and computer-aided design and manufacturing, with the aim of improving accuracy, reproducibility, and efficiency.

Accurate digital recording of the maxillomandibular relationship remained a critical factor influencing occlusal outcomes. Digital bite registration techniques performed at intercuspal position or centric relation, with or without digital facebow transfer, were expected to affect occlusal accuracy and the extent of chairside adjustment required at delivery.

Virtual articulators were developed to simulate mandibular movements using digitally acquired data. These systems required accurate digital impressions, occlusal records, and appropriate orientation of the maxillary arch relative to craniofacial reference planes. Digital facebow systems enabled virtual transfer of maxillary position and were expected to improve mounting accuracy compared with average-value articulators alone.

Study objectives Primary Objectives

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

Participants are blinded to the type of digital bite registration method used to fabricate each of the four Michigan occlusal splints. Each participant is required to try four splints in a crossover manner, with splints coded and presented in identical appearance so that participants cannot distinguish which recording method was used for any given splint. Clinicians and researchers involved in splint fabrication and assessment are not blinded.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and
  • Able to provide informed consent.
  • Have no more than one tooth missing per quadrant.

排除标准

  • Patients with removable dentures
  • Patients receiving medication for psychological disorders.
  • Patients diagnosed with systemic joint disorders.
  • Pregnant.
  • Patients who have received TMD treatment in the last 6 months.
  • Deep bite cases.
  • Those who have an extreme class 3 dental or skeletal relationship.

研究组 & 干预措施

Retruded axis position(RAP with) without a digital facebow

Experimental

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including Retruded axis position(RAP with) without a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

干预措施: Digital face-bow, digital bite registration, digital scanning (Device)

Retruded axis position(RAP) with a digital facebow.

Experimental

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including Retruded axis position(RAP) with a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

干预措施: Digital facebow, digital bite registration, digital scanning (Device)

Intercuspal position (ICP) with a digital facebow

Experimental

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including maximum intercuspal position (ICP) with a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

干预措施: Retruded axis position(RAP with) without a digital facebow (Device)

Intercuspal position (ICP) without a digital facebow.

Experimental

Each participant received Michigan occlusal splints fabricated using digital bite registration methods, including maximum intercuspal position (ICP) without a digital facebow. Participants try each splint in a crossover manner while being blinded to the recording method used. Occlusal accuracy and adjustment requirements are evaluated using three-dimensional surface superimposition and root mean square (RMS) deviation analysis.

干预措施: Digital face-bow, digital bite registration, digital scanning (Device)

结局指标

主要结局

Volumetric occlusal adjustment of michigan occlusal splints

时间窗: Baseline (pre-adjustment) and at splint fitting (post-adjustment)

The primary outcome was the volume of occlusal adjustment required for Michigan occlusal splints fabricated using different digital bite registration workflows. Volumetric changes were quantified by calculating root mean square (RMS) deviation values between pre-adjustment and post-adjustment digital scans of each splint using three-dimensional surface comparison software. Higher RMS values indicated greater occlusal adjustment.

次要结局

  • Occlusal contact quality after adjustment of michigan occlusal splints(At splint fitting visit)

研究者

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

Arwa Alhusban

Dr Arwa Ibrahim Alhusban

King's College London

研究点 (1)

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