| CTRI Number |
CTRI/2020/12/029529 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
25/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
The dislocation of Jaw Joint is assessed using special CT. |
|
Scientific Title of Study
|
The evaluation of imaging modality to determine the ideal treatment modalities in patients with TMJ Dislocation- A prospective clinical study |
| Trial Acronym |
CBCT- TMJD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LOGITHA SRI S |
| Designation |
PG Student |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
Department of Oral and Maxillofacial Surgery, SRM dental College, Ramapuram, Chennai- 600089. Department of Oral and Maxillofacial Surgery, SRM dental College, Ramapuram, Chennai- 600089. Chennai TAMIL NADU 600089 India |
| Phone |
9148379219 |
| Fax |
|
| Email |
drlogithasri.s@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
SASIKALA B |
| Designation |
READER |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089. Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089. Chennai TAMIL NADU 600089 India |
| Phone |
9148379219 |
| Fax |
|
| Email |
sasiomfs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
LOGITHA SRI S |
| Designation |
PG Student |
| Affiliation |
SRM DENTAL COLLEGE |
| Address |
Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089. Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuram, Chennai - 600089. Chennai TAMIL NADU 600089 India |
| Phone |
9148379219 |
| Fax |
|
| Email |
drlogithasri.s@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharathi Salai, SRM DENTAL COLLEGE, Ramapuram, Chennai- 600089. |
|
|
Primary Sponsor
|
| Name |
LOGITHA SRI S |
| Address |
Department of Oral and Maxillofacial Surgery, SRM Dental College, Ramapuam, Chennai - 600089. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr LOGITHA SRI S |
SRM DENTAL COLLEGE |
Ground floor, Department of OMFS, SRM DENTAL COLLEGE, RAMAPURAM, CHENNAI - 600089. Chennai TAMIL NADU |
9148379219
drlogithasri.s@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, (2) ICD-10 Condition: M244||Recurrent dislocation of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with TMJ Dislocation into study group and normal into control group
2) No previous TMJ surgeries
|
|
| ExclusionCriteria |
| Details |
1) Patient with previous history of TMJ surgery
2) Patient with age <18 and >50
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
condylar head height,
condylar head width,
articular eminence height, articular eminence inclinaion |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
condylar head height,
condylar head width,
articular eminence height, articular eminence inclinaion |
baseline |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
04/12/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subluxation or dislocation of the temporomandibular joint (TMJ) is an acutely painful condition in which the condyle glides out of the glenoid fossa with inability to descend back to normal position. The incidence of dislocation is 7% . It occurs due to imbalance in the neuromuscular function, structural variation in eminence, fossa, or condyle and laxity of the ligaments &capsule. Dislocation is precipitated spontaneously or by trauma,aging and changes in the dentition, wide mouth opening, certain antipsychotic medications, and some syndromes. Dislocation is commonly mismanaged because of improper localization of pathology. The treatment for TMJ Dislocation is generally done based on creating or removing the obstacle in condylar movement. Here, in this study we are going to measure the osseous anatomy of TMJ components to determine the discrepancy using Cone Beam Computed Tomography (CBCT). The CBCT allows measurement of TMJ bony structures with high accuracy. Also proposing new Diagnostic Algorithm to choose the Ideal treatment option for the respective discrepancy. RESEARCH AIM: This study was therefore designed to analyze the discrepancy in the osseous component of the TMJ and to propose a diagnostic algorithm to choose the ideal treatment protocol. MATERIALS AND METHODS: o SAMPLE SELECTION: 50 patients with age of 18 to 50 were recruited into the study and allotted into two groups. CONTROL GROUP:(n=25)Patients with no history of subluxation. STUDY GROUP:(n=25)Patients with history of subluxation. o Clinical evaluation included assessment of mouth opening, clicking and pain. o Radiologic evaluation using CBCT. o PARAMETERS: CBCT evaluation included measurement of -width and height of condylar head. -width, height and inclination of articular eminence. RESULTS/FINDINGS: To compare mean and standard deviation of parameters between study and control groups independent samples unpaired t-test was applied. For variables which did NOT follow Normal distribution, to compare between study and control groups wilcoxon test was used. CONCLUSION: Relative ratio of the depth of glenoid fossa to height of articular eminence which can predispose to dislocation was determined. This was called the critical ratio. Patients with lower critical ratio required osseous surgery while patients with higher ratio required soft tissue surgery. |