| CTRI Number |
CTRI/2026/03/107143 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess changes in pain and jaw function after nanofat injection in adults with temporomandibular joint disorder |
|
Scientific Title of Study
|
Assessment of pain relief and functional improvement following intra articular nanofat grafting in adults with temporomandibular joint internal derangement: A prospective interventional study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Jaseel S V |
| Designation |
1st Year MDS PG |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral and Maxillofacial Surgery,Yenepoya Dental College, Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8606872334 |
| Fax |
|
| Email |
jachusv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinayakrishna K |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral and Maxillofacial Surgery,Yenepoya Dental College, Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9535625002 |
| Fax |
|
| Email |
drvinnykolari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muhammed Jaseel S V |
| Designation |
1st Year MDS PG |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral and Maxillofacial Surgery,Yenepoya Dental College, Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8606872334 |
| Fax |
|
| Email |
jachusv@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Muhammed Jaseel S V |
| Address |
Department of Oral and Maxillofacial Surgery, Yenepoya Dental College,Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
|
| 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 |
| Muhammed Jaseel S V |
Yenepoya dental college |
Oral and Maxillofacial Surgery department ,1st floor,Yenepoya University, University Road, Deralakatte, Mangaluru, Karnataka 575018
Dakshina Kannada
KARNATAKA |
8606872334
jachusv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee 2 |
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 |
Intra articular autologous nanofat grafting |
Autologous nanofat prepared from abdominal subcutaneous adipose tissue using standard emulsification technique and injected intra articularly into the superior joint space of temporomandibular joint under aseptic conditions. Single sitting procedure. Patients followed up for assessment of pain relief and functional improvement using validated clinical parameters.
Duration is for 3 months per person,follow up time line of 15 days,1 month and 3 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients aged between 18–50 years
-Patients with ASA class 1 and 2 physical status
-Patients clinically diagnosed with disc displacement with
reduction or disc displacement without reduction
according to DC/TMD Axis I diagnostic criteria.
-Patients who are refractory to conservative management for more than a period of 3 months.
-Patients willing to undergo abdominal fat harvesting and intra-articular nanofat injection
|
|
| ExclusionCriteria |
| Details |
-Local infection at donor or recipient site
-Lactating or pregnant women
-Previous Temporomandibular joint surgery or intra-articular injections within 6 months
-Systemic steroid or immunosuppressive therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in TMJ pain intensity measured using Visual Analog Scale (VAS) and improvement in functional limitation assessed using Jaw Functional Limitation Scale (JFLS) |
Baseline,15 days, 1 month,3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in maximum mouth opening (mm) |
Baseline,15 days, 1 month,3 months |
| Improvement in lateral mandibular movements (mm) |
Baseline,15 days, 1 month,3 months |
|
|
Target Sample Size
|
Total Sample Size="17"
Sample Size from India="17"
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)
|
10/06/2026 |
| 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
|
Temporomandibular disorders (TMD-ID) are a common cause of chronic orofacial pain and functional limitation affecting mastication and quality of life. Persistent symptoms despite conservative management necessitate evaluation of alternative therapeutic modalities. This single-arm interventional study aims to evaluate the efficacy of intra-articular nanofat graft injection in patients clinically diagnosed with temporomandibular disorder internal derangement (TMD-ID) based on the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) Axis I. The primary objective of the study is to assess the effectiveness of intra-articular nanofat graft injection in reducing pain and improving mandibular function in patients with TMD-ID. A total of 9 participants (17 temporomandibular joints) will be included in the study. Following baseline clinical assessment, eligible patients will receive intra-articular nanofat graft injection under aseptic conditions. Participants will be followed up at 1 week, 1 month, and 3 months post-procedure. At each visit, pain intensity, maximum mouth opening, mandibular movements, and functional limitation will be assessed. The total duration of follow-up for each participant will be 3 months.
|