| 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
|
|
|
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
|
|
|
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. |