| 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
|
|
|
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
|
|
|
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 “Prolotherapyâ€. 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. |