| CTRI Number |
CTRI/2022/09/045320 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [injectable platelet rich fibrin ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of injectable platelet rich fibrin in tempromandibular joint disorders. |
|
Scientific Title of Study
|
Comparative evaluation of the role of injectable platelet rich fibrin with Diclofenac Sodium in patients with temporomandibular disorders - 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 |
Aishla Jain |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
room number 104 , oral health sciences centre , PGIMER, sector 12 , chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9686849065 |
| Fax |
|
| Email |
aishlajain10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VIDYA RATTAN |
| Designation |
PROFESSOR |
| Affiliation |
PGIMER |
| Address |
room number 104 , oral health sciences centre , PGIMER, sector 12 , chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914900871 |
| Fax |
|
| Email |
drvidyarattan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishla Jain |
| Designation |
Junior Resident |
| Affiliation |
PGIMER |
| Address |
room number 104 , oral health sciences centre , PGIMER, sector 12 , chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9686849065 |
| Fax |
|
| Email |
aishlajain10@gmail.com |
|
|
Source of Monetary or Material Support
|
| room number 104 , oral health sciences , PGIMER ,chandigarh |
|
|
Primary Sponsor
|
| Name |
Aishla Jain |
| Address |
room number 104 , oral health sciences centre ,PGIMER,sector 12 , chandigarh |
| Type of Sponsor |
Other [self] |
|
|
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 |
| VIDYA RATTAN |
PGIMER |
104 , ORAL HEALTH SCIENCE CENTERE
Chandigarh
CHANDIGARH |
9914900871
drvidyarattan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , PGIMER |
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 |
Diclofenac Sodium |
50 mg tablet BD ( twice a day )
for 14 days
|
| Intervention |
Injectable platelet rich fibrin |
i-PRF injection of 2 ml in each joint .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with internal derangement of TMJ disorders classified under Wilkes stage II, III, IV and V. |
|
| ExclusionCriteria |
| Details |
Autoimmune diseases
1.Benign or malignant
temporomandibular joint lesions
2.Neurological disorders,
3. Blood diseases and coagulation
disorders
4. Allergies or anaphylactic shock.
5. History of peptic ulcers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain—VISUAL ANALOGUE SCALE. |
0 day , 14 days 30 days , 60 days , 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) The range of mandibular motion (maximum unassisted opening (MUO), maximum
assisted opening (MAO), protrusive movement (PM), right lateral excursion (RLE) and left
lateral excursion (LLE)
2) Tenderness of masticatory muscle – by manual palpation
3) Clicking sound |
0 day , 14 days 30 days , 60 days , 90 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2022 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study design is prospective, parallel arm randomized controlled trial to evaluate and compare the effectiveness of iPRF for relief of signs and symptoms in specific subgroups of temporomandibular disorders. The objectives of the study are to assess and compare the effect of iPRF on temperomandibular disorders in term of pain , tenderness, clicking and limited range of motion. The primary outcome measure will be assessment of pain through visual analogue scale and secondary outcome measures will be assessment of range of mandibular motion, tenderness of masticatory muscles – by manual palpation and clicking sound.
|