| CTRI Number |
CTRI/2023/03/050477 [Registered on: 09/03/2023] Trial Registered Prospectively |
| Last Modified On: |
08/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
a study to compare the effect of joint lavage ,blood centrifuge and combination of two in patients with jaw joint problem |
|
Scientific Title of Study
|
COMPARISON OF ARTHROCENTESIS, INJECTABLE PLATELET RICH FIBRIN AND COMBINATION OF THE TWO IN PATIENTS WITH UNILATERAL TEMPOROMANDIBULAR JOINT INTERNAL DERANGEMENT: 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 |
Ram Sundar Chaulagain |
| Designation |
Junior Resident |
| Affiliation |
AIIMS,RISHIKESH |
| Address |
2nd floor,Department of dentistry and craniomaxillofacial surgery,AIIMS RISHKESH VIRBHADRA ROAD DEHRADUN ,UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7607010021 |
| Fax |
|
| Email |
ramrefresh16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashi Chug |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,RISHIKESH |
| Address |
2nd floor,Department of dentistry and craniomaxillofacial surgery,AIIMS RISHKESH VIRBHADRA ROAD DEHRADUN ,UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
|
| Fax |
|
| Email |
ashichug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ram Sundar Chaulagain |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
|
| Address |
2nd floor,Department of dentistry and craniomaxillofacial surgery,AIIMS RISHKESH VIRBHADRA ROAD DEHRADUN ,UTTARAKHAND
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7607010021 |
| Fax |
|
| Email |
ramrefresh16@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS RISHIKESH, VIRBHADRA ROAD ,DEHRADUN ,UTTARAHAND |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [no sponsor ] |
|
|
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 |
| Ram Sundar Chaulagain |
AIIMS Rishikesh |
2nd floor,Department of dentistry and craniomaxillofacial surgery,AIIMS RISHKESH VIRBHADRA ROAD DEHRADUN ,UTTARAKHAND
Dehradun
UTTARANCHAL |
7607010021
ramrefresh16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE AIIMS RISHIKESH |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, (2) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arthrocentesis followed by i-PRF injection |
Arthrocentesis is performed with the standard double needle puncture technique with 150-200ml of Ringers lactate. After the arthrocentesis process is completed, the second needle will be removed with the first needle in place. i-PRF is injected through the first needle immediately after the arthrocentesis |
| Comparator Agent |
ARthrocentesis of temporomandibular joint |
Technique: Standard double puncture arthrocentesis
Holmlund –Hellsing line (i.e canthotragus line) is taken as the landmark for the puncture sites.
2 guiding points are marked with reference to Holmlund –Hellsing line over the skin. The first point is 10 mm ahead of tragus and 2 mm below Holmlund –Hellsing line. The second point is 20 mm ahead and 10 mm inferiorly in the same line (indicates site of TMJ eminence). The Auriculotemporal nerve block is given, and 18-gauge needle is inserted from 1st point followed by injection of 2mL Ringers Lactate solution into the joint space. The second needle also of 18 gauge is inserted from the second guide point. The pressurized washing is done with 5% ringer lactate solution and volume of 150-200ml injecting from first needle and exit from the second needle
|
| Intervention |
i-PRF injection |
PREPARATION OF i-PRF
Blood for the preparation is withdrawn from the medial cubital /cephalic vein under aseptic condition. Patient is seated erect with back supported with the supported forearm in supine position. The site is inspected to identify the suitable vein. The tourniquet is applied and the patient is made to make the fist. After identifying the suitable vein, the part was cleansed with the antiseptic solution. 10 ml needle was carefully inserted in the identified vein with bevel facing upward and when blood appears in the needle hub the needle is slightly pushed inside by about 1-4 mm and the blood was withdrawn. Thus, collected blood was transferred into the sterile glass tubes without anticoagulant. The tube was immediately centrifuged at 700rpm for 3 minutes with the help of PRF centrifuge machine . After centrifugation, two layers were identified the bottom layer of red blood cells and the top layer of i-PRF . The upper layer was collected with a 3 ml needle.
block is performed with local anesthesia
. The articular fossa is located at a point 10 mm anterior and 2 mm below the canthotragus line.
. 2 mL i-PRF injected in the articular cavity and 1mL in the pericapsular tissue with 24gauge needle.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age: More than 18 years or less than or equal to 50 years.
Unilateral temporomandibular disorder (Wilkes II, III, IV)
Painful TMD
Occasional difficulty in mouth opening
|
|
| ExclusionCriteria |
| Details |
Age18 or less and more than 50
Pregnant female
Autoimmune diseases such as osteoarthritis and rheumatoid arthritis
Patient allergic to local anaesthesia
Patient in whom magnetic resonance imaging (MRI) is contraindicated
Patient with history of TMJ surgery
Patient with the congenital or developmental disorder of TMJ
Benign or malignant TMJ lesions
Patients refusing to attend all scheduled visits
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluate and compare three different methods of management i.e., arthrocentesis, i-PRF injection, and a combination of the two in unilateral temporomandibular disorder in terms of TMJ pain relief, based on VAS scale evaluated after the 3rd month post intervention. |
10 th day ,1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To assess the change in maximum inter-incisal mouth opening
• To assess the change in lateral and protrusive movement
To evaluate the effect on the clicking of the joint
• To evaluate the effect in the deviation and deflection of mandible
• To evaluate the effect on the muscles of mastication
• To assess the impact of internal derangements on the quality of the life using oral health impact questionnaire
• To assess the severity of the temporomandibular disorder using the Fonseca questionnaire
• To assess the psychological aspect of the patient based on the perceived stress scale questionnaire
• To evaluate the disc changes following the intervention through the Magnetic Resonance Imaging (MRI) based on the following variables in MRI findings:
1. Shape of the disc
2. Relation between disc and condyle
3. Signal intensity in joint space
4. Degree of disc displacement
|
clinical evaluation at 10h day,1 month and 3 months and oral health impact,perceived stress scale questionnare and Fonseca questionnare at 0 and 3rd month |
|
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Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
15/03/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Temporomandibular
disorders appear to be common problem and have major impact in the quality of
the life. Various management modalities such as splints, physiotherapy,
arthrocentesis, intra-articular injections of agents like HA, PRP and i-PRF have
been used for the relief of the symptoms primarily pain and reduced mouth
opening. Arthrocentesis
is minimal invasive procedure that can be performed without significant
complications. The significant positive clinical outcomes, cost effectiveness
and the minimal use of the armamentarium has increased its application in
management of TMD. The development of the i-PRF and the studies related to
i-PRF in the patients with TMD showed significant positive effects in reduction
of the symptoms. i-PRF can
be easily prepared and is obtained from the patient’s own blood with no significant
intra-operative and post intervention complication such as allergic reactions
due to the blood concentrate used. Hence, it
seems logical to use i-PRF individually or arthrocentesis combined with i-PRF. Hence, the study is being conducted to compare the
three different modalities of management in the patients with temporomandibular
disorder. |