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CTRI Number  CTRI/2019/01/017076 [Registered on: 14/01/2019] Trial Registered Prospectively
Last Modified On: 16/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARING PLATELET RICH PLASMA AGAINST HYALURONIC ACID INJECTIONS FOR THE TREATMENT OF JAW JOINT DISORDERS  
Scientific Title of Study   EFFICACY OF INTRA-ARTICULAR PLATELET RICH PLASMA VERSUS HYALURONIC ACID AFTER ARTHROCENTESIS FOR THE TREATMENT OF INTERNAL DERANGEMENTS OF THE TEMPOROMANDIBULAR JOINT – A RANDOMIZED CONTROLLED TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shiju Mathew Jacob 
Designation  Resident 
Affiliation  Army Dental Center Research and Referral, Army Hospital Research and Referral 
Address  Department of Oral and Maxillofacial Surgery
Army Dental Center Research and Referral Army Hospital Research and Referral Dhaula Kuan Delhi Cantt
New Delhi
DELHI
110010
India 
Phone  9994664774  
Fax    
Email  askthedoc_shiju@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr PK Chattopadhyay 
Designation  Associate Professor 
Affiliation  Army Dental Center Research and Referral, Army Hospital Research and Referral 
Address  Department of Oral and Maxillofacial Surgery
Army Dental Center Research and Referral Army Hospital Research and Referral Dhaula Kuan Delhi Cantt
New Delhi
DELHI
110010
India 
Phone  9958676834  
Fax    
Email  colpkc2008@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shiju Mathew Jacob 
Designation  Resident 
Affiliation  Army Dental Center Research and Referral, Army Hospital Research and Referral 
Address  Department of Oral and Maxillofacial Surgery
Army Dental Center Research and Referral Army Hospital Research and Referral Dhaula Kuan Delhi Cantt
New Delhi
DELHI
110010
India 
Phone  9994664774  
Fax    
Email  askthedoc_shiju@yahoo.co.in  
 
Source of Monetary or Material Support  
Army Dental Center Research and Referral Army Hospital Research and Referral Dhaula Kuan Delhi Cantt New Delhi 110010 
 
Primary Sponsor  
Name  Army Dental Center Research and Referral 
Address  Army Hospital Research and Referral Dhaula Kuan Delhi Cantt -110010 
Type of Sponsor  Research institution and hospital 
 
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 Shiju Mathew Jacob  Army Dental Centre Research and Referral  Department of Oral and Maxillofacial Surgery Army Dental Centre Research and Referral Army Hospital Research and Referral Dhaula Kuan
New Delhi
DELHI 
9994664774

askthedoc_shiju@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Dental Center Research and Refferal Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Arthrocentesis  Conventional arthrocentesis procedure with 100 ml Ringers lactate solution will be performed.  
Intervention  Hyaluronic acid  Conventional arthrocentesis procedure with 100 ml Ringers lactate solution will be performed. 01ml of Hyaluronic acid (Inj. Hyalosyn) will be infused into the upper joint space using the needle in the entry port. The second needle in the exit port will be withdrawn prior to Hyaluronic acid injection.  
Intervention  Platelet rich plasma  Conventional arthrocentesis procedure with 100 ml Ringers lactate solution will be performed. Approximately 06 ml of fresh blood will be drawn from the patient for one joint and equally distributed to sterile vaccutainers coated with an anti-coagulant (acid-citrate-dextrose, 3.2% sodium citrate). These tubes will be centrifuged in 1000 rpm for 10 minutes at room temperature to obtain three typical layers: Red Blood Cells (RBCs) at the deepest, a‘buffy coat’ in the middle, including 01 cm limited in the upper part of the RBCs and acellular plasma (PPP, Platelet-Poor Plasma) in the upper part. The upper part of the acellular plasma is the plasma poor in growth factors (PPGF) and is discarded from each tube meticulously. The remaining buffy coat, that is the PRP, will be collected separately. 01ml of PRP thus obtained will then be injected into the upper joint space without activating it. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients with symptomatic TMD’s categorized under Wilkes classification Type II - disc displacement with reduction and intermittent locking and Wilkes Type III - acute disc displacement without reduction.
2.Poor prognosis to conservative management.
3.Patients giving consent for the study.
 
 
ExclusionCriteria 
Details  1.Patient with any previous invasive procedures on TMJ.
2.Patient with inflammatory or connective tissue diseases.
3.Any bony pathology associated with TMJ.
4.Direct trauma to or fracture of facial bones involving the condyle.
5.Allergic to local or topical anesthetics.
6.Patients undergoing psychiatric treatment.
7.Patients undergoing orthodontic treatment and orthognathic procedures.
8.Patients with debilitating co-morbidities.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Reduction of pain
2.Reduction of joint sounds.
3.Improvement in mouth opening.
4.Improvement in other possible excursive movements of the mandible. 
Follow-up will be done at 1 week, 1 month, 3 months and 6 months and data will be collected 
 
Secondary Outcome  
Outcome  TimePoints 
None  None 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 24/08/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   "none yet" 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Temporomandibular joint disorder (TMD) is a common source of orofacial pain and is characterized by pain, joint noise, limited range of motion, impaired jaw function, deviation or deflection upon mouth opening, malocclusion and closed or open locking. The term temporomandibular joint (TMJ) internal derangement is used synonymously to describe displacement of the articular disc. Though there are many conservative as well as surgical modalities available for management of TMD, only a few have been proved foolproof. The primary goals of the treatment for TMD are pain relief and increasing the range of mandibular motion. The milestone in the treatment of TMJ internal derangement was with the introduction of TMJ arthroscopy and methods for lysis and lavage of the upper joint space by arthrocentesis.

 The lavage and lysis of the upper joint compartment under local anesthesia enables the disc to slide to its normal anatomic position, thus re-establishing the normal range of mandibular functions. Intra-articular administration of medications is an established method of treatment, particularly for rheumatic disorders that are associated with pain, effusion, inflammation of cartilage, bone and joint capsules as well as fibrous adhesions.

The aim of this prospective study is to compare the efficacy of arthrocentesis followed by intra-articular administration of PRP vs arthrocentesis followed by intra-articular administration of hyaluronic acid in patients with anterior disc displacement of the TMJ with or without reduction in order to minimize the symptoms which were unresponsive to conservative treatment modalities.


 
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