| CTRI Number |
CTRI/2024/07/071130 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| 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
|
Effect of low-voltage electrical current and Low-dose Laser light in relieving Ear joint pain among patients aged between 25 to 50 years |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) and Low-Level Laser therapy (LLLT) in symptomatic Temporomandibular Disorders |
| 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 DebasreeBoral |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R Ahmed Dental College & Hospital |
| Address |
Dr. R Ahmed Dental College & Hospital,
Department of Oral Medicine & Radiology,
Room No: BG (Ground Floor)
114, A. J. C Bose Road,
Kolkata-700014, West Bengal
Kolkata
WEST BENGAL
700014
India |
| Phone |
9831766391 |
| Fax |
|
| Email |
drdebasreeboral27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DebasreeBoral |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R Ahmed Dental College & Hospital |
| Address |
Dr. R Ahmed Dental College & Hospital,
Department of Oral Medicine & Radiology,
Room No: BG (Ground Floor)
114, A. J. C Bose Road,
Kolkata-700014, West Bengal
Kolkata
WEST BENGAL
700014
India |
| Phone |
9831766391 |
| Fax |
|
| Email |
drdebasreeboral27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr DebasreeBoral |
| Designation |
Assistant Professor |
| Affiliation |
Dr. R Ahmed Dental College & Hospital |
| Address |
Dr. R Ahmed Dental College & Hospital,
Department of Oral Medicine & Radiology,
Room No: BG (Ground floor)
114, A. J. C Bose Road,
Kolkata-700014, West Bengal
Kolkata
WEST BENGAL
700014
India |
| Phone |
9831766391 |
| Fax |
|
| Email |
drdebasreeboral27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Oral Medicine & Radiology , Ground Floor, Dr. R. Ahmed Dental College & Hospital, 114, A. J. C Bose Road, Kolkata-700014, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
Dr R Ahmed Dental College Hospital |
| Address |
Department Oral Medicine & Radiology , Ground Floor, Dr. R. Ahmed Dental College & Hospital, 114, A. J. C Bose Road, Kolkata-700014, West Bengal, India |
| Type of Sponsor |
Other [Government Dental College] |
|
|
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 Debasree Boral |
Dr. R Ahmed Dental College & Hospital |
Department Oral Medicine & Radiology , Ground Floor, Dr. R. Ahmed Dental College & Hospital, 114, A. J. C Bose Road, Kolkata-700014, West Bengal, India
Kolkata
WEST BENGAL |
9831766391
drdebasreeboral27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Dr. R. Ahmed Dental College & Hospital, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low-Level Laser therapy (LLLT) |
Its mechanism of action includes increasing the mitochondrial activity, affecting the sodium-potassium pump, and increasing vascularization.
Total 8 sessions will be given, 2 sessions per week for 1 month.
|
| Intervention |
Transcutaneous Electric Nerve Stimulation (TENS)
|
Transcutaneous Electric Nerve Stimulation (TENS);TENS equipment produces a low-amplitude, low-frequency alternating stimulus that causes muscles to contract and relax.
Total 8 sessions will be given, 2 sessions per week for 1 month.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
History of TMD-related pain for the past 3 months
Not taking any antidepressant medications
Patients falling in Research Diagnostic Criteria for TMJ disorders (RDC/TMD)
Patients willing to participate in this study
|
|
| ExclusionCriteria |
| Details |
Five or more missing posterior teeth (except for the third molars)
Parafunctional habits (bruxism and clenching)
Impacted 3rd molars
Degenerative joint disorder
Patients with cardiac pacemakers, malignancy, or any other severe systemic illness
Those patients who were not willing to undergo treatment
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of TENS and LLLT in reducing TMD-related pain.
To compare the effectiveness of TENS and LLLT.
|
the outcome will be assessed at baseline, after 2 weeks & after 4 weeks.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of TENS & LLLT |
the outcome will be assessed at baseline, after 2 weeks & after 4 weeks. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="0"
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
|
The study will be carried out on patients reporting to the Department of Oral Medicine and Radiology, Dr. R Ahmed Dental College & Hospital, Kolkata, clinically diagnosed with TMD associated with temporomandibular joint (TMJ) pain, clicking sound, pain in the muscles of mastication and with or without limited mouth opening. Total 44 patients with the age range, 25–50 years, will be randomly selected from OPD, after obtaining informed consent. 44 patients will be randomly divided into two groups (group-A, group-B) of 22 each by an individual not participating in the study. •Group-A will treated with TENS therapy for eight sessions (2 sessions per week), using a WBIDFC TENS 4 CH. device with 20 W power, 220 v voltage, and 50 Hz frequency, continuous mode for 10 minutes. •Group-B will treated with LLLT for eight sessions (2 sessions per week), using a INDILASE diode laser in continuous wave mode with 810 nm wavelength, 0.2 W power, 10 sec time and 2 J/cm2 energy density. The pain score (0-10, where 0 represents no pain and 10 represents the worst pain as perceived by the patient subjectively) will be evaluated before, during (mid-treatment), and after treatment using the visual analogue scale (VAS). Inter-incisal mouth opening will be recorded before, during (mid-treatment), and after treatment using a vernier caliper. The present study is aimed to evaluate and compare the efficacy of TENS and LLLT, as an adjunct to medication in patients with TMD. |