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CTRI Number  CTRI/2025/06/088609 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 11/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   MRI-Based Comparison of Joint Changes After Arthrocentesis Using Single- vs Double-Puncture SPA Type II Needle Techniques 
Scientific Title of Study   Comparison of changes in the disco-condylar complex using MRI after arthrocentesis with spa type II needle single- puncture versus double-puncture technique  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Richa sharma 
Designation  junior resident 1 
Affiliation  Santosh deemed to be university 
Address  Department of oral and maxillofacial surgery, Santosh dental College and hospital, Ghaziabad, Uttar Pradesh
Sector-16B, supertech ecovillage 2, towerb15, flat no.308, Greater Noida West, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201009
India 
Phone  08585968147  
Fax    
Email  risharma11122@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Richa sharma 
Designation  junior resident 1 
Affiliation  Santosh deemed to be university 
Address  Department of oral and maxillofacial surgery, Santosh Dental College and Hospital, Ghaziabad, Uttar Pradesh
Sector-16B, supertech ecovillage 2, tower b15, flat no.308, Greater Noida West,Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201009
India 
Phone  08585968147  
Fax    
Email  risharma11122@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Richa sharma 
Designation  junior resident 1 
Affiliation  Santosh deemed to be university 
Address  Department of oral and maxillofacial surgery, santosh dental College and hospital, Ghaziabad, Uttar Pradesh
Sector-16B, supertech ecovillage 2,towerb15,flat no.308, Greater Noida West, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201009
India 
Phone  08585968147  
Fax    
Email  risharma11122@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Santosh Dental College and Hospital 
Address  Department of oral and maxillofacial surgery, Santosh Dental College and Hospital, Ghaziabad, Uttar Pradesh 
Type of Sponsor  Other [NIL] 
 
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 Richa Sharma  Santosh Dental college and Hospital, ghaziabad, uttar pradesh  Department of Oral and maxillofacial surgery, Santosh Dental College and Hospital, Santosh deemed to be university, Ghaziabad, Uttar Pradesh,201009
Ghaziabad
UTTAR PRADESH 
08585968147

risharma11122@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee of Santosh deemed to be university  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients with temporomandibular joint (TMJ) disorders, internal derangement of the TMJ(DDWOR), leading to symptoms like pain, limited mouth opening, clicking sounds, and functional limitations. 
Patients  (1) ICD-10 Condition: R298||Other symptoms and signs involvingthe nervous and musculoskeletal systems,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Double -puncture arthrocentesis technique  In the double-puncture technique, the first needle is inserted at Point A (Point A will be marked 10 mm anterior to the tragus and 2 mm downward from the Hollumuland-Helsing line.) and a second needle is placed 10 mm anterior and below the Hollumuland-Helsing line, followed by irrigation with at least 100 ml of Ringer’s lactate. 
Intervention  Single-puncture arthrocentesis technique   single-puncture technique using a SPA Type II needle involves irrigating the TMJ with Ringer’s lactate via a cannula inserted at a 45° angle until the joint space is reached. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Patients with age between 18-60 years.
• Patient with wilkies stage II TMJ disorder (anterior disc displacement with reduction).
• Patient with pain, clicking in TMJ and restricted mouth opening.  
 
ExclusionCriteria 
Details  • Patient with wilkies stage III TMJ disorder and above
• Patient with hematological disorder and connective tissue disease.
• Patient with history of repeated arthrocentesis.
• Patient with history of previous TMJ surgery.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN PAIN ON FUCTION, MAXIMUM MOUTH OPENING, LATERAL AND PROTRUSIVE MOVEMENTS AND TMJ CLICKING SOUNDS  Assessed on 15 days,1 month and 3 months.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   N/A 
Date of First Enrollment (India)   30/06/2025 
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="0"
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  

Temporomandibular joint (TMJ) disorders will continue to pose significant clinical challenges, often causing pain, restricted function, and reduced quality of life. One of the most prevalent TMJ internal derangements will be disc displacement without reduction (DDWOR), which will be characterized by an anteriorly displaced articular disc and symptoms like limited mouth opening and discomfort. While conservative treatments will usually serve as first-line management, arthrocentesis—a minimally invasive procedure—will likely prove effective for early-stage internal derangements by releasing adhesions and improving disc function. The standard double-puncture arthrocentesis technique, although effective, may be time-consuming and may pose challenges such as needle dislocation. To address these issues, a single-puncture technique using the SPA Type II needle will be developed to simplify the procedure by combining inflow and outflow in one needle, potentially reducing complications and operating time. This randomized controlled study will aim to compare the outcomes of single- versus double-puncture arthrocentesis on the disco-condylar complex using MRI. The study will involve 24 patients divided into two groups, and it will use pain scores, maximum mouth opening, lateral and protrusive movements, clicking, and MRI evaluation of the disco-condylar complex as outcome measures. By providing clinical insights into the efficacy of these techniques, the findings will guide clinicians in selecting optimal treatment approaches for TMJ disorders, ultimately improving patient outcomes and supporting the use of minimally invasive procedures.

 
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