跳至主要内容
临床试验/CTRI/2025/07/090719
CTRI/2025/07/090719招募中不适用

Morphometric evaluation of temporomandibular joint using cone-beam computed tomography and association of clinical dysfunction index in patients with temporomandibular disorders

Dr Shruthi Hegde1 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2025年7月28日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
276
试验地点
1
主要终点
To compare and evaluate difference in the morphology and morphometric features of the temporomandibular joint in patients with and without temporomandibular disorders

研究概览

简要总结

Present study will be conducted to evaluate the morphometric parameters of the patients with and without TMD and to compare the morphometric features with the clinical dysfunction index.

Research Question

Do morphometric features of TMJ differ in patients with TMD and without TMD and do

morphometric features have an association with the clinical severity of TMD?

Methodology

A standard protocol will be followed for the diagnosis of the new patients reporting to the department. Patients will be explained in detail about the study, and informed consent will be obtained from the patients willing to participate. The study will be comprised of a total of 276 patients. The control group (Group I) includes 138 patients without TMD and the study group (Group II) includes 138 patients with TMD. Selective sampling method will be used to ensure similar age and sex distribution in the control group as the study group in order to avoid any arbitrary effect on study results. Study group will be further categorized into 3 subgroups according to the Research Diagnostic Criteria. Patient demographic details, history and clinical signs and symptoms recording will be carried out in data collection forms. The patients will be evaluated according to clinical dysfunction index. Depending on the total score obtained, patients will be classified as having a clinical Di between 0 and 4. CBCT analysis will be carried out for 552 joints (276 right side and 276 left side joints of 276 patients). The morphologic features and morphometric parameters such as mandibular condyle shape, glenoid fossa shape, condylar bony changes, condylar height, condylar width, anterior joint space, posterior joint space, superior joint space, glenoid fossa roof thickness, glenoid fossa width, glenoid fossa depth  will be evaluated  and analysed in the study.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Inclusion Criteria for Study Group 1.Patients reporting with complaint of pain in the TMJ region or muscles of mastication and diagnosed with Temporomandibular joint disorders(TMD) according to the Research Diagnostic Criteria (RDC/TMD).
  • 2.Patients who are willing to participate in the study.
  • Patients in the age group of 18 to 60 years Inclusion criteria for control group 1.Patients without Temporomandibular joint disorders (Helkimo clinical index =0) and require Cone beam computed tomography(CBCT) for the diagnosis and treatment planning 2.Patients who are willing to participate in the study 3.Patients in the age group of 18 to 60 years.

排除标准

  • Exclusion Criteria for Study Group 1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces
  • Pregnancy
  • Patients with CBCT images having inadequate clarity or resolution Exclusion criteria for control group 1.Patients with a history of trauma, TMJ surgery, congenital abnormalities, neuromuscular disorders, patients presenting with a history of any tumour or growth in the orofacial region that can influence the morphology of the condyle or affect the dimensions of the joint spaces 2.Patients with history of systemic arthritis 3.Images with inadequate field of view (FOV) 4.Patients with CBCT images having inadequate clarity or resolution 5.Presence of degenerative changes in the CBCT images.

结局指标

主要结局

To compare and evaluate difference in the morphology and morphometric features of the temporomandibular joint in patients with and without temporomandibular disorders

时间窗: at baseline

次要结局

  • To compare & evaluate the clinical, radiographic & morphometric features with types of temporomandibular disorders(at baseline)

研究者

发起方
Dr Shruthi Hegde
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Shruthi Hegde

A B Shetty Memorial Institute of Dental Sciences affiliated to Nitte (Deemed to be University)

研究点 (1)

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