| CTRI Number |
CTRI/2024/09/073175 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of post operative outcomes in treatment of fracture of joint of lower jaw with jaw fixation to each other with or without Arthrocentesis . |
|
Scientific Title of Study
|
Comparative Evaluation Of Functional Outcomes Of High Condylar Fractures Managed By Closed Treatment With And Without Temporomandibular Joint Arthrocentesis - A Randomised Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Sachindra Dubey |
| Designation |
Post Graduate (Oral Surgery) |
| Affiliation |
Sharad Pawar Dental College And Hospital,Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Oral and Maxillofacial surgery, Room no. 004, Sharad Pawar Dental College and Hospital, Sawangi, Wardha, Maharashtra
Datta Meghe Institute of Medical Sciences Campus, Sawangi, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000747554 |
| Fax |
- |
| Email |
dubey12shachidra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nitin Bhola |
| Designation |
Head of Department And Proffessor |
| Affiliation |
Sharad Pawar Dental College And Hospital,Datta Meghe Institute Of Higher Education and Research |
| Address |
Department of Oral and Maxillofacial surgery, Room 004, Sharad Pawar dental college and hospital
Datta Meghe Institute of Medical Sciences Campus, Sawangi, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000747554 |
| Fax |
- |
| Email |
drnitinbhola@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sachindra Dubey |
| Designation |
Post Graduate ( Student) |
| Affiliation |
Sharad Pawar Dental College And Hospital,Datta Meghe Institute Of Higher Education and Research |
| Address |
Department Of Oral and Maxillofacial surgery, Room no. 004, Sharad Pawar dental College and Hospital, Sawangi, Wardha
Datta Meghe Institute of Medical Sciences Campus, Sawangi, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000747554 |
| Fax |
- |
| Email |
dubey12shachidra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sharad Pawar Dental college and Hospital, Datta Meghe Institute Of Medical Sciences Campus, Sawangi, Wardha, Maharashtra, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Sachindra dubey |
| Address |
Department of Oral and Maxillofacial surgery,Sharad Pawar Dental college and Hospital, Datta Meghe Institute Of Medical Sciences Campus, Sawangi, Wardha, Maharashtra, India, 442001 |
| 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 Sachindra Dubey |
Sharad Pawar Dental College And Hospital |
Department of Oral and Maxillofacial surgery, Room no 004, SPDC, Sawangi
Wardha
MAHARASHTRA |
7000747554
dubey12shachindra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute Of Higher Education And Research, Instituional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S026||Fracture of mandible, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthrocentesis With Closed Reduction In High Condylar Fractures |
Tmj Arthrocentesis Will Be Performed In Unilateral High Condylar Fracture With Double Lumen Single Barrel Needle done once in 1st week. |
| Comparator Agent |
Patients Treated With Closed Reduction Without Arthrocentesis. |
Closed Reduction Done For Patients With Unilateral High Condylar Fracture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with unilateral high condylar fractures.
2)Sagitally fractured unilateral high condylar fractures.
3)Intracapsular fractures in unilateral condyle
4)Patients with panfacial fractures including unilateral high condylar fractures.
5)Patients within age group of 18 - 60 years.
6)Patients with ASA Gr I status.
|
|
| ExclusionCriteria |
| Details |
1) Patients with bilateral high condylar fractures.
Subcondylar fractures
2)Patients with Extra- capsular fractures of condyle.
3) Patients with H/O medical comorbidities contraindicating closed reduction of condyles (ex- epilepsy).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain as measured on VAS score panel And Increase in Mouth opening (inter-incisal distance) |
Reduction in pain as measured on VAS score panel And Increase in Mouth opening (inter-incisal distance). Following Parameters will be assessed on 7th post operative day, 1st and later at 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased Bite force, Improved occlusal stability, Smooth Lateral excursive movements |
over 3-6 week period |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
·
This study would put forth the utility of Arthrocentesis as
an adjunct procedure with closed reduction in high condylar fractures, to
provide improvement in the functionality of condyle, relief in pain, increase
in mouth opening and bite force, Stablise bilateral occlusion, and normal
excursive moments. |