| CTRI Number |
CTRI/2025/12/098716 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
08/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Jaw joint pain treatment using two different intra joint injections |
|
Scientific Title of Study
|
Effectiveness of Injectable Platelet-Rich Fibrin (i-PRF) vs Hyaluronic Acid in the Treatment of Internal Derangement of the Temporomandibular Joint (TMJ): A MRI-Based Prospective Randomized Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satheesh G |
| Designation |
Reader |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Reader Room, Department of Oral and maxillofacial surgery
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9952124010 |
| Fax |
|
| Email |
gsatheeshdental@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satheesh G |
| Designation |
Reader |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Reader room, Department of Oral and MAxillofacial surgery
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9952124010 |
| Fax |
|
| Email |
gsatheeshdental@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satheesh G |
| Designation |
Reader |
| Affiliation |
Adhiparasakthi dental college and hospital |
| Address |
Reader Room, Department of Oral and maxillofacial surgery
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9952124010 |
| Fax |
|
| Email |
gsatheeshdental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adhiparasakthi dental college and Hospital, Melmaruvathur |
|
|
Primary Sponsor
|
| Name |
SATHEESH G |
| Address |
Department of Oral and maxillofacial surgery, Adhiparasakthi dental college and hospital, Melmaruvathur |
| 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 |
| Dr SATHEESH G |
Adhiparasakthi dental college and hospital |
Reader room, Department of oral and maxillofacial surgery
Kancheepuram
TAMIL NADU |
9952124010
gsatheeshdental@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Adhiparasakthi dental college and hospital Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyaluronic acid |
Arthrocentesis as per Nitzan’s technique followed by injection of Commercially available non-crosslinked hyaluronic acid preparation (e.g., 1 mL) into the upper joint space. Clinical evaluation done at baseline, 1 week, 1 month and 3 months for pain, mouth opening and joint sounds.MRI evaluation of TMJ Disc and associated structures done at baseline and at 3 months. |
| Intervention |
Injectable Platelet-Rich Fibrin |
Autologous blood collection 10ml and centrifugation using low-speed centrifugation
protocol (e.g., 700 rpm for 3 min). Arthrocentesis as per Nitzan’s technique
followed by 2ml i-PRF injection into the superior joint space under aseptic
conditions. Clinical evaluation done at baseline, 1 week, 1 month and 3 months for pain, mouth opening and joint sounds.MRI evaluation of TMJ Disc and associated structures done at baseline and at 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Patients aged 18 to 50 years
Diagnosed with internal derangement of TMJ Wilkes stage two to four for whom conservative management has failed
Unilateral or bilateral involvement
Willing to provide informed consent and attend follow up visits |
|
| ExclusionCriteria |
| Details |
Systemic joint diseases
Other systemic diseases that can affect the joint health
Previous TMJ surgery or injection
TMJ ankylosis
Wilkes stage one and five
Pregnancy or lactation.
Coagulation disorders or platelet dysfunction.
Claustrophobic patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
MRI-based evaluation(both at closed and open mouth) at baseline and 3months
post-injection for
1. Disc position (normalized, partially improved, unchanged, worsened).
2. Joint space (increased/reduced/normal).
3. Superior Bands of lateral pterygoid muscle position
Clinical Outcome
1. Pain (VAS score 0–10) at baseline, 1 week, 1 month and 3 months.
2. Maximum mouth opening (mm).
3. Joint sounds (clicking/crepitus).
|
baseline, 1 week, 1 month and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional limitations (chewing, yawning, speech).
Patient satisfaction (Likert scale)
Biochemical analysis of fluid obtained during arthrocentesis- To look for
inflammatory mediators/Proteins |
baseline, 1 week, 1 month and 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study compares the efficacy of injectable platelet rich fibrin and hyaluronic acid as intra articular injection in managing internal derangement of TMJ. Although there are very few studies with similar intent, the novelty of the study lies in objectively evaluating the Pre and Post intervention MRI scan images. Objective evaluation is necessary to know regarding the sustainability of the treatment outcome. |