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CTRI Number  CTRI/2024/05/067932 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 26/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study efficiency of patient specific 3D printed guides for lavage and lysis of temporomandibular joint compared to conventional method– A prospective clinical trial 
Scientific Title of Study   Evaluation of arthrocentesis using 3d printed guide versus conventional arthrocentesis in the treatment of internal derangement with reduction of temporomandibular joint– A Randomised control 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 Sandhya Kokitkar 
Designation  Postgraduate Trainee 
Affiliation  Government Dental college and Hospital Mumbai 
Address  Government Dental college and Hospital, P D mellow road, Mumbai

Mumbai
MAHARASHTRA
400001
India 
Phone  9637646374  
Fax    
Email  sandhyakokitkar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavita Wadde 
Designation  HOD, Department of Oral and Maxillofacial surgery 
Affiliation  Government Dental college and Hospital Mumbai 
Address  Government Dental college and Hospital P D Mellow Road Mumbai


MAHARASHTRA
400001
India 
Phone  9004799405  
Fax    
Email  dr.kavitawadde@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandhya Kokitkar 
Designation  Postgraduate Trainee 
Affiliation  Government Dental college and Hospital Mumbai 
Address  Government Dental college and Hospital P D Mellow Road Mumbai


MAHARASHTRA
400001
India 
Phone  9637646374  
Fax    
Email  sandhyakokitkar@gmail.com  
 
Source of Monetary or Material Support  
Government Dental college and Hospital P D Mellow Road Mumbai 400001 Maharashtra India  
 
Primary Sponsor  
Name  Dr Sandhya kokitkar 
Address  Government Dental College and Hospital,Mumbai P D Mellow road, Fort, Mumbai 400001 Maharashtra India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sandhya kokitkar  Government Dental college and hospital Mumbai  118, Department of Oral and Maxillofacial surgery, Government Dental college and hospital P D mellow road Mumbai
Mumbai
MAHARASHTRA 
9637646374

sandhyakokitkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital,Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M272||Inflammatory conditions of jaws, (2) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arthrocentesis using 3D printed guides  3D printed guides are patient-specific and made using software based on DICOM images of CT scans of individuals. This procedure will be performed only once on OPD basis for individual 
Comparator Agent  Conventional Arthrocentesis  Conventional Arthrocentesis using two needle technique. This procedure will be performed only once on OPD basis for individual 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient with internal derangement of TMJ with reduction of disc
2.Patients not responding to conservative therapy (Diet, pharmacotherapy, physical therapy, behavioural therapy, occlusal therapy)
3.Patients who are willing to participate in the study.
4.Patients with ASA I and ASA II.
 
 
ExclusionCriteria 
Details  1.Patients with degenerative disorders of joint. (Osteoarthritis)
2.Patients with disc perforation.
3.rheumatoid arthritis/psoriatic arthritis
4.Patients with tenderness of TMJ secondary to myalgias or MPDS
5.Patient with history of Condylar fracture
6.Patient with excessive adipose tissue in facial region which will interfere with proper placement of patient specific guides.
7. Patients with severe systemic conditions. (ASA III And ASA IV)
8.Pregnant and lactating patient.
9.Patient with previous history of TMJ arthrocentesis, arthroscopy or surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease the number of attempts thus avoiding multiple punctures,
Minimal damage to TMJ and surrounding structures, Bridge the gap between arthroscopy and arthrocentesis
 
outcomes will assisted intraoperatively,7th day, 1st month,3months 6months postoperative. 
 
Secondary Outcome  
Outcome  TimePoints 
complications of arthrocentesis using both technique  outcomes will assisted intraoperatively,7th day, 1st month,3months 6months postoperative. 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
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)   07/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  07/06/2024 
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 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  

EVALUATION OF THE EFFICACY OF ARTHROCENTESIS USING PATIENT SPECIFIC GUIDE IN THE TREATMENT OF INTERNAL DERANGEMENT WITH REDUCTION OF TEMPOROMANDIBULAR JOINT - A COMPARATIVE STUDY.

 

The temporomandibular joint (TMJ) forms one of the most fascinating and complex synovial joints in the body. Temporomandibular disorders (TMDs) are defined as clinical problems involving the masticatory musculature and the TMJ associated structures or both. Treatment strategy for TMDs consists of various nonsurgical and surgical methods. Arthrocentesis of TMJ has emerged over the years as a useful technique to manage TMDs.

Arthrocentesis, a simple minimally invasive technique is generally suggested in patients irresponsive to conservative therapies. Arthrocentesis requires experienced hand and takes multiple punctures to enter the joint space with subsequent post-operative discomfort and probability for facial nerve injury.

Thus, to overcome the shortcomings of manual arthrocentesis 3d printed guides has been designed with help of ct scan. Patient with internal derangement of TMJ with reduction of disc between age of 21 to 60 years will be included in the study. Efficacy of these guides will be compared with manual arthrocentesis by comparing Time required for procedure, Number of attempts required to insert needle into superior space, Patients discomfort during procedure, Post operative pain, Maximal Mouth opening, Presence of joint sound, Postoperative complications, Cost effectiveness.

 
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