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临床试验/NCT04661670
NCT04661670Unknown不适用

Relief of Signs and Symptoms in Patients With Tempro-mandibular Disorders Using Occlusal Stabilization Splints Equilibrated by T-scan Versus Articulating Paper: A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
28
试验地点
1
主要终点
Relief of TMD Signs and symptoms

研究概览

简要总结

The objective of the study is to evaluate if occlusal stabilization splints equilibrated by articulating paper will have equivalent effect in comparison to occlusal stabilization splints equilibrated by T-scan regarding the relief of the TMD signs and symptoms

详细描述

Eligible patient will be selected from Outpatient Clinic in Prosthodontics Department clinic. Patients will be informed of the nature of the research work and informed consent will be obtained from each of them.All patients will be assessed for TMJ health following DC/TMD Axis I and II to confirm the diagnosis . Base line pain scale and range of pain free jaw movements (mm) will be recorded before starting the treatment. Patients will be randomly divided into 2 equal groups; occlusal stabilization splints equilibrated by articulating paper and occlusal stabilization splints equilibrated by T-scan

Patients of both groups will be subjected to:

Primary impressions will be taken using rubber base impression material (Zhermac zetaplus impression material) ,the impressions will be poured twice to construct 2 study casts to be used for final occlusal adjustment of the splint. Maxillary Face-bow record will be done to mount both maxillary casts on a semi adjustable articulator (A7-Plus Bio Art semi-adjustable articulator) using different mounting rings.

Bite registration using bite registration material (Futar D Bite Registration Material - Ultra Rigid from Kettenbach LP ) will be done in centric relation after deprogramming the muscles using acrylic jig or leaf gauges, followed by loading test for condyle position verification 7to mount the mandibular cast. A protrusive record will be made at 6 mm mandibular protrusion to set the horizontal condylar guidance, while lateral condylar guidance will be adjusted at fixed value of 15 degrees.

The centric relation will be verified by comparing the first point of contact intraorally and the first point of contact on the articulator will be verified. The maxillary cast will be surveyed to detect teeth height of contour. The borders of the occlusal splint will be drawn on the maxillary cast to be occlusal to the height of contour buccally and to extend 1-2 mm beyond the gingival margin on the palatal surface. As the jaw relation and mounting will be done by leaf gauges and at elevated vertical dimension, the incisal pin will be kept on zero. The appliance will be waxed up by filling the inter-arch space with pink wax placed will taper it to a feather edge to the previously drawn borders. A complete arch coverage design will be done and will be shaped to be flat. The wax will be checked with 20 um thick articulating paper (AccuFilm, parkell, USA)and should produce bilateral posterior contacts in coincidence with physiologic condylar seating and a smooth anterior guidance in excursions allowing posterior disocclusion2

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
Single (Outcomes Assessor)

盲法说明

The outcome assessor and statistician will be blinded. It is not possible to blind neither the participant nor the care provider

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult cooperative patients who have bruxism and TMD of myogenous origin (Age: 18-60)
  • •Fully dentate or partial edentulous patients with no more than one missing tooth per quadrant, excluding third molars
  • •presence of signs and symptoms of TMD ( diffuse pain in head and neck, headache pain exaggeration by jaw movements, restricted jaw movements)
  • •severe Disc displacement with or without reduction who can be treated by stabilization appliance (Reciprocal click, or without click)

排除标准

  • •Use of removable dentures
  • •More than one absent tooth per quadrant
  • •Patients with anterior open bite
  • •Severe systemic conditions or somatic symptoms, depression and anxiety
  • •Trauma of recent date towards face, head or neck
  • •Dentoalveolar pathology or ongoing treatment related to TMD.
  • •patients scheduled for dental procedures that could alter the occlusion during therapy

研究组 & 干预措施

occlusal stabilization splints equilibrated by articulating paper

Active Comparator

In this group the final occlusal correction will be performed with the patient in supine position using 20 um thick articulating paper and articulating foil 8 um thick. The patient will be asked to tap 3 times on the articulating paper and occlusal correction will be done using carbide laboratory bur and rubber cone till uniform contact on all teeth is achieved in centric relation which is illustrated on the splint by a series of uniformly appearing articulating paper dots. Then the patient will be asked to make protrusive and right and left excursions to ensure smooth anterior guidance and posterior disocclusion.

干预措施: occlusal stabilization splints (Device)

occlusal stabilization splints equilibrated by T-scan

Active Comparator

In this group the same adjustment sequence will be done using T Scan III (software version 8.0) computerized occlusal analysis, a new patient file will be opened, the patient's biological data will be entered, and the T Scan dental arch size is customized to fit the patients arch anatomy. The patient will be asked to clench to record occlusal force and areas that needs adjustment will be grinded using the paper marks as the guideline and carbide laboratory bur till bilateral force balance achieved and the center of force (COF) icon sits close to the midline.

Mandibular excursions are then adjusted in a similar fashion. Contacts rather than anterior and canine guidance will be eliminated till achieving anterior guidance and posterior disocclusion in time less than 0.5 seconds.

干预措施: occlusal stabilization splints (Device)

结局指标

主要结局

Relief of TMD Signs and symptoms

时间窗: 3 months

Graded pain scale questionnaire (VAS scale)

Increased range of painless jaw movements

时间窗: 3 months

Jaw functional questionnaire (VAS scale)

次要结局

  • measurement of range of jaw movements (maximum un assisted opening , protruion, right and left excrusion)(3 months)

研究者

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

Sara Eman Saad el Din

Assistant lecturer

Cairo University

研究点 (1)

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