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CTRI Number  CTRI/2024/06/068839 [Registered on: 13/06/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   The study is looking at whether irrigation in a joint procedure, or taking a medication by mouth, or doing both together is the best way to treat jaw joint problems. 
Scientific Title of Study   A randomized controlled trial comparing the effectiveness of arthrocentesis alone, oral duloxetine alone, and a combination of both in the treatment of temporomandibular joint disorders. 
Trial Acronym  Tmj 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjay Joshi 
Designation  Hod and professor  
Affiliation  Terna dental college and hospital 
Address  Terna dental college plot no. 12, sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India)

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  sanjoshi99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Joshi 
Designation  Hod and professor  
Affiliation  Terna dental college and hospital 
Address  Terna dental college plot no. 12, sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India)

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  9869057337  
Fax    
Email  sanjoshi99@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Damini Hiralal Nikhar  
Designation  Post graduate student 
Affiliation  Terna dental college and hospital 
Address  Terna dental college plot no. 12, sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India)

Mumbai (Suburban)
MAHARASHTRA
400706
India 
Phone  7757823883  
Fax    
Email  damini21nikhar@gmail.com  
 
Source of Monetary or Material Support  
TERNA DENTAL COLLEGE, Plot No 12, Terna Campus Rd, opposite Railway Station, opposite Nerul West, Nerul East, Sector 22, Nerul, Navi Mumbai, Maharashtra 400706 
 
Primary Sponsor  
Name  Dr Damini Hiralal Nikhar 
Address  Terna dental college plot no 12, sector 22, Nerul(W), Navi Mumbai, Maharashtra(India) Pin - 400706 
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 Damini Hiralal Nikhar  Terna dental college  Terna dental college plot no. 12, sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) pin – 400706
Thane
MAHARASHTRA 		 7757823883

damini21nikhar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arthrocentesis  All patients requiring minor oral surgical procedure having tmj pain with vas score 5 or more. 
Intervention  Arthrocentesis with oral duloxetine  All patients requiring minor oral surgical procedure having tmj pain with vas score 5 or more. 
Intervention  Oral duloxetine  All patients requiring minor oral surgical procedure having tmj pain with vas score 5 or more. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient willing to participate in study.
2.Patients in the age group of 18 -60 years.
3.Patients diagnosed with TMJ arthralgia and intra articular TMJ disorders as given by DC TMD criteria.
4.Patients with VAS score 5 or more pre-operatively
 
 
ExclusionCriteria 
Details  1.Patients having systemic diseases in which duloxetine is contraindicated.
2.Patients with coagulation disorders.
3.Allergic reaction to local anesthetic agents and duloxetine.
4.TMJ pain following traumatic injury.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in reducing pain in temporomandibular joint disorders.  VAS score at day1, day7, 1st month, 3rd month 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in improving the maximum mouth opening in temporomandibular joint disorders  Maximum mouth opening at day1, day7, 1st month,3rd month 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
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 4 
Date of First Enrollment (India)   18/07/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Temporomandibular disorder (TMD) is a musculoskeletal disorder within the masticatory system. It has an adverse effect on jaw function so that patients may present with limited mouth opening or difficulty in chewing because of pain and locking in the temporomandibular joint (TMJ).
Most TMJ disorders include internal derangement which has been described as conditions in which the articular disc has become displaced from its original position in relation to the condylar head and articular eminence. The displacement of the disc can result in numerous presentations, with the most common being disc displacement with reduction (with or without intermittent locking) and disc displacement without reduction (with or without limited opening). TMJ disorder presents with symptoms like pain, joint sounds, and jaw function issues. Accurate diagnosis involves history, clinical examination, and imaging. Effective management is crucial to alleviate pain and maintain joint function.
Arthrocentesis is defined as a procedure in which the fluid in a joint cavity is aspirated with a needle and a therapeutic substance is injected. Duloxetine inhibits serotonin and norepinephrine reuptake, addressing central sensitization in chronic pain. In TMJ disorder, it reduces IL-6 production, easing inflammation and pain.
The purpose of this study is to evaluate the efficacy of arthrocentesis, oral duloxetine alone and combination of arthrocentesis with oral duloxetine in reducing pain and improving the maximum mouth opening in temporomandibular joint disorders.
 
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