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CTRI Number  CTRI/2019/01/017056 [Registered on: 11/01/2019] Trial Registered Prospectively
Last Modified On: 11/01/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two intrarticular injections (dextrose versus autologus blood) in temporomandibular joint disorders 
Scientific Title of Study   Comparison of role of Autologous Platelet rich plasma and dextrose prolotherapy in chronic degenerative disorders of temporomandibular joint: A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Chugh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Jodhpur, Rajasthan 
Address  DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Room no. 208,DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  08003996891  
Fax    
Email  chugha@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ankita Chugh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Jodhpur, Rajasthan 
Address  DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Room no. 208,DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  08003996891  
Fax    
Email  chugha@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Ankita Chugh 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences,Jodhpur, Rajasthan 
Address  DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Room no. 208,DEPARTMENT OF DENTISTRY, All India Institute of Medical Sciences,Jodhpur, Rajasthan
Jodhpur
RAJASTHAN
342005
India 
Phone  08003996891  
Fax    
Email  chugha@aiimsjodhpur.edu.in  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, Jodhpur 
 
Primary Sponsor  
Name  All India Institute of medical sciences 
Address  Basni Industrial area jodhpur 
Type of Sponsor  Government medical college 
 
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 ANKITA MODY  ALL INDIA INSITUTE OF MEDICAL SCIENCES  BASNI INDUSTRIAL AREA, JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN 
08003996891

chugha@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M199||Osteoarthritis, unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AUTOLOGOUS BLOOD PRP  2 ML WILL BE INJECTED AROUND TMJ, If partial relief is there then repeat injections is given at interval of 3 weeks and 6 weeks 
Intervention  DEXTROSE   2 ml of 12.5% dextrose is to be injected in joint, If partial relief is there then repeat injections is given at interval of 3 weeks and 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients with internal derrangement of TMJ with pain, joint sounds and restricted mouth opening 
 
ExclusionCriteria 
Details  1. patients with myofascial pain dysfunction syndrome
2. immunocompromised patients
3. patients with platelet disorders or who have taken NSAIDS in past one week or those who have undergone corticosteroid injection intra articular in last two months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
comparison of efficiency of PRP and dextrose in relieving TMD symptoms  follow up weekly for 1 month and then at 2,4 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
COMPLICATIONS ASSOCIATED  follow up weekly for 1 month and then at 2, 4 and 6 months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   12/01/2019 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Temporomandibular disorder (TMD) is one of the most common diseases causing chronic orofacial pain. Temporomandibular Joint (TMJ) is often predisposed to degenerative changes and pathologies as seen in other synovial joints, as a consequence of the frequent and repetitive stresses that the TMJ undergoes. Symptoms commonly associated with TMD include pain at the TMJ, generalized orofacial pain, chronic headaches and ear aches, jaw dysfunction, including limited movement or locking of the jaw, painful clicking or popping sounds with opening or closing of the mouth, and difficulty in chewing or speaking. Chronic pain is now recognized as a complex disorder that persists past the normal time of healing and as pain persists, psychosocial issues including depression, maladaptive beliefs about pain, medication abuse, strained interpersonal relationships andineffective coping strategies become prominent aspects of the disorder. For this disorders conservative measures like muscle relaxants, transcutaneous electrical neural stimulation (TENS), hot and cold fomentation, occlusal splints or intraarticular injections of steroids and hyaluronidase have been used. In non-refractory cases arthrocentesis and arthroscopic procedures are also done. Chronic cases not responding to any treatment may have to undergo open joint surgeries as well. For a chronic joint pain a therapy which can create a favorable environment for inflammation and augments the natural healing process of the body appears promising. This approach is referred to as Proliferation injection therapy/ Regenerative injection therapy popularly known as “Prolotherapy”. The agents used in prolotherapy are of four type’s namely osmotic agents, inflammatory mimetics, chemical irritants and physical irritants. Osmotic agent that is commonly used is 12.5% dextrose with local anesthetic agent. These agents produce a hypertonic extracellular environment and cause lysis of the adjacent cell walls. The resultant release of cellular proteins, inflammatory breakdown products of the cell wall and debris brings macrophages and granulocytes to the area and the desired localized inflammation and fibrous healing begin. Thus prolotherapy reinitiates the inflammatory process thereby augmenting the natural healing process of the body by stimulating fibroblastic activity. It can also induce the functional reactivation of tissues such as ligaments, disc and tendons.

Another kind of reparative injection therapy used for its varied regenerative and reparative is platelet rich plasma.Platelet rich plasma is a natural concentrate of autologous blood growth factor which is obtained by sequestering and concentrating platelets by gradient density centrifugation. It has been experimented in different fields of medicine in order to test its potential to enhance tissue regeneration. These platelets when activated undergo degranulation to release growth factors with healing properties. It also contains plasma, cytokines, thrombin, and other growth factors that are implicated in wound healing and have inherent biological and adhesive properties. The advantages of this method would be the safety of the material and a zero possibility of hypersensitivity to injected plasma. Clinically, it is used for neural damage, osteoarthropathy, myocardial injury, bone regeneration, and also in plastic surgery. There have been just a few studies for the treatment of TMD using PRP or prolotherapy with dextrose. These studies have mainly assessed pain as a factor.To the best of our knowledge no clinical studies assessing the overall symptoms related to TMD including the intensity of pain, range of motion, and TMJ sound have been conducted.Therefore the aim of this study is to evaluate and compare the efficacy of intraarticular injection therapy with 12.5% dextrose and platelet-rich plasma (PRP) for the patients who have the TMD symptoms of pain, restricted mouth opening, and TMJ sound.

 
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