| CTRI Number |
CTRI/2025/11/097152 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Non invasive magnetic field therapy for Jaw Joint pain |
|
Scientific Title of Study
|
Efficacy of Pulsed Electromagnetic Field Therapy for pain management in patients with Temporomandibular Joint Disorders- A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashish Ravi Kallur |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9663211708 |
| Fax |
|
| Email |
ashishkallur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nagachandran K S |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884152660 |
| Fax |
|
| Email |
nagachandranks.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Nagachandran K S |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9884152660 |
| Fax |
|
| Email |
nagachandranks.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu. |
|
|
Primary Sponsor
|
| Name |
Ashish Ravi Kallur |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu. |
| 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 Nagachandran K S |
Saveetha Dental College |
Department of Orthodontics and Dentofacial Orthopaedics,
Saveetha Dental College & Hospitals,
Saveetha Institute of Medical and Technical Sciences
Saveetha University
Chennai, Tamilnadu.
Thiruvallur
TAMIL NADU |
9663211708
nagachandranks.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
Placebo |
PEMF device in switched off mode |
| Intervention |
Pulsed electromagnetic field (PEMF) therapy |
PEMF therapy given for 30 mins everyday for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
History of orofacial pain for more than 2 months
History of known temporomandibular joint disorder(TMD)
Tenderness of muscles and joints of temporomandibular joint(TMJ)
|
|
| ExclusionCriteria |
| Details |
History of psychological disorders
Implanted electric device in the body |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pain |
End of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion |
End of trial |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
Final Enrollment numbers achieved (Total)= "19"
Final Enrollment numbers achieved (India)="19" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/11/2025 |
| Date of Study Completion (India) |
15/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/04/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ashishkallur@gmail.com].
- For how long will this data be available start date provided 31-07-2026 and end date provided 31-07-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
A randomized, double-blind, placebo-controlled clinical trial investigating the efficacy of pulsed electromagnetic field (PEMF) therapy for patients with chronic temporomandibular joint disorder conditions. Forty six adult participants were assigned either to active PEMF therapy group(n=23) or to a control group(n=23) receiving sham therapy with identical protocols. The protocol involved daily sessions over a period of four weeks, with primary outcomes assessed via pain scales such as the Visual Analogue Scale, functional measures, and medication use at intervals throughout and following the intervention. |