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临床试验/CTRI/2020/11/029024
CTRI/2020/11/029024尚未招募不适用

ASSESSMENT OF A MORPHOFUNCTIONAL APPROACH TO TEMPOROMANDIBULAR JOINT ANKYLOSIS AND A PROTEOMIC AND GENOMIC STUDY OF THE DISEASE

Yenepoya University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2020年11月18日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
47
试验地点
2
主要终点
Maximum Incisal opening

研究概览

简要总结

Aimof the study

Assessment of a Morphofunctional Approach to TemporomandibularJoint Ankylosis and a Proteomic and Genomic Study of the Disease.

Objectivesof the study

1.               Comparison of a morphofunctional approach withconventional interpositional arthroplasty    for themanagement of TMJ ankylosis.

2.               To identify possible geneticmarkersof TMJ ankylosis by miRNA and exome sequencing

3.               To identify protein expression and molecularsignaling pathways involved in TMJ ankylosis  through phospho-proteomicevaluationand compare with normal controls.

4.               To propose a staging systemforTMJ ankylosis correlating the clinical, functional and radiographic features.

OBJECTIVE 1: Comparisonof a morphofunctional approach with conventional****interpositionalarthroplasty for the management of TMJ ankylosis.

21 cases of conventionalinterpositional arthroplasty [repositorydata and prospective cases to be operated at Yenepoya (Deemed to be) Universityand GSR Institue] will becompared with a minimum of 21 cases operatedat the GSR Institute, Hyderabad, using the morphofunctionaltechnique i.e Osteotomy modification+ cartilage graft for reconstruction

Maximum IncisalOpening (MIO) will be measured pre and post- operatively and will be comparedbetween the groups.

Incidence of reankylosiswill be assessed and compared between the groups

OBJECTIVE 3: Genetic basis of TMJankylosis

5 ml of venous bloodwill be collected from 5 patients with TMJ ankylosis and 5 healthy controls asdescribed previously and will be subjected to miRNA and exome sequencing

OBJECTIVE 3: Phospho-proteomic analysis of theankylotic mass

Resected ankyloticmasses from 5 patients with TMJ ankylosis and resected normal(non  ankylosed) condyles from 5 controls will be collected andstored as described previously and subjected to phospho-proteomic evaluation.

OBJECTIVE4: To propose a staging system for TMJ ankylosis correlating the****clinical,functionaland radiographic features.

Photographic,radiographic and functional assessment will be carried out to propose a stagingsystem for TMJ ankylosis based on the severity and extent of the disease.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
1.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • a)Patients diagnosed with unilateral/bilateral, fibrous/bony ankylosis of the TMJ.
  • b)Patients consenting for investigations and treatment c)AHA I, II and III patients.

排除标准

  • a)Patients with restricted mouth opening due to causes other than ankylosis (non articular causes) such as muscle spasm, condylar fractures, oral submucous fibrosis, benign and malignant tumors.
  • b)Patients not fit for surgery under general anesthesia due to severe systemic illnesses (AHA IV and V).

结局指标

主要结局

Maximum Incisal opening

时间窗: Every month for the first 6 months, once in 3 months for the next one year and bi annually for the next two years.

Incidence of reankylosis

时间窗: Every month for the first 6 months, once in 3 months for the next one year and bi annually for the next two years.

次要结局

  • Aesthetic and functional outcome(Annual assessment post-operatively)

研究者

申办方类型
Private medical college

研究点 (2)

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