| 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
|
|
|
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
|
|
|
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. |