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
|
|
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
|
|
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
|
|
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. |