| CTRI Number |
CTRI/2025/08/092993 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Therapeutic Ultrasound and TENS in TMJ disorders. |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of Therapeutic Ultrasound and Transcutaneous Electrical Nerve Stimulation in Temporomandibular Joint Disorder: A Randomized Controlled Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trupti Doma Gharde |
| Designation |
Post Graduate Student |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Department no.2A, Sinhgad Dental College and Hospital, S. No. 44/1,Vadgaon Budruk,off Sinhgad Road,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9822271079 |
| Fax |
|
| Email |
trupti.g1508@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Chavan |
| Designation |
Professor and HOD |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Department no.2A, Sinhgad Dental College and Hospital, S. No. 44/1,Vadgaon Budruk,off Sinhgad Road,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9823623445 |
| Fax |
|
| Email |
drmaheshschavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Chavan |
| Designation |
Professor and HOD |
| Affiliation |
Sinhgad Dental College and Hospital, Pune |
| Address |
Department of Oral Medicine and Radiology, Department no.2A, Sinhgad Dental College and Hospital, S. No. 44/1,Vadgaon Budruk,off Sinhgad Road,Pune
Pune
MAHARASHTRA
411041
India |
| Phone |
9823623445 |
| Fax |
|
| Email |
drmaheshschavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology (2A), Sinhgad Dental College and Hospital, Survey No. 44/1, Vadgaon Budruk, Off Sinhgad Road, Pune – 411041, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Trupti Doma Gharde |
| Address |
Department of Oral Medicine and Radiology (2A), Sinhgad Dental College and Hospital, Survey No. 44/1, Vadgaon Budruk, Off Sinhgad Road, Pune – 411041, Maharashtra, India |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Mahesh Chavan |
Sinhgad Dental College and Hospital, Pune |
Department of Oral Medicine and Radiology, Department no.2A, Sinhgad Dental College and Hospital, S. No. 44/1,Vadgaon Budruk,off Sinhgad Road,Pune
Pune
MAHARASHTRA |
9823623445
drmaheshschavan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sinhgad Dental College and Hospital, Survey No. 44/1, Vadgaon Budruk, Off Sinhgad Road, Pune – 411041, Maharashtra, India |
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 |
| Intervention |
Therapeutic ultrasound
|
Therapeutic ultrasound (Th US) is a noninvasive therapeutic method which includes vibrations above 16,000 vibrations/s or 16 Hz (range audible to the human ear). The frequency used is between 1.0 and 3.0 MHz. This therapy given for 4 weeks with gap of 2 days in each session.
|
| Comparator Agent |
Transcutaneous electrical nerve stimulation |
Transcutaneous electrical nerve stimulation (TENS) in this therapy the application of pulse duration of 50–200 µs and frequency of 50 mA–100 mA applied through surface electrodes, for 4 weeks with gap of 2 days in each session.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged above 18 years with pain associate with TMD will be included as per RDC/TMD criteria.
Patient who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Temporomandibular joint dislocation
Malignancy in head and neck region
Open wounds, burns ,infections or fracture at operating region.
Systemic disorders
Presence of metal implants in TMJ.
Hairy surfaces interfering with assessment
Neurological and Radiological deficits
Pregnant women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain sensation using Visual Analogue Scale |
Baseline
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0"
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
|
Participants: - A total of 40 patients aged 18 years and above, diagnosed with Temporomandibular Joint Disorders based on Research Diagnostic Criteria for Temporomandibular Disorders criteria, will be selected.
- They will be randomly divided into two groups:
- Group I: Transcutaneous Electrical Nerve Stimulation therapy (20 patients)
- Group II: Therapeutic Ultrasound therapy (20 patients)
Intervention: - Group I Transcutaneous Electrical Nerve Stimulation therapy:
- Patients will receive 15-minute Transcutaneous Electrical Nerve Stimulation therapy sessions, twice a week, for 4 weeks.
- Electrical stimulation will be applied via electrodes placed over the Temporomandibular Joint.
- Group II Therapeutic Ultrasound therapy:
- Patients will undergo 5–10-minute therapeutic ultrasound sessions, twice a week, for 4 weeks.
- Continuous mode ultrasound at 1.0–3.0 MHz frequency will be used.
Assessment: - Pain will be evaluated using the Visual Analog Scale before and after each session.
- Clinical signs of TMD will be recorded as per Research Diagnostic Criteria for Temporomandibular Disorders criteria.
- Patients will be followed up monthly for 3 and 6 months.
Study Design and Analysis: - The study will be a randomized controlled trial with allocation concealment and double blinding.
- Data will be collected and statistically analyzed using suitable tests (e.g., t-test, Wilcoxon, ANOVA) to compare the effectiveness of Transcutaneous Electrical Nerve Stimulation therapy and Therapeutic Ultrasound therapy.
|