| CTRI Number |
CTRI/2024/01/061872 [Registered on: 25/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of TENS and Low Level Laser Therapy (LLLT) in TMJ disorder patients |
|
Scientific Title of Study
|
Evaluation of TENS and Low Level Laser Therapy (LLLT) in patients with Temporomandibular joint disorder - A Pilot 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 |
Vishalini K |
| Designation |
Post graduate |
| Affiliation |
Rajas dental college and hospital |
| Address |
Department of oral medicine and radiology,
Ground floor,
Room No: 1
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli
Tirunelveli
TAMIL NADU
627105
India |
| Phone |
9363621529 |
| Fax |
|
| Email |
vishalinikalaivanan98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Angeline Deepthi |
| Designation |
Professor and Head of the department |
| Affiliation |
Rajas dental college and hospital |
| Address |
Department of oral medicine and radiology,
Ground floor,
Room No: 1,
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli
Tirunelveli
TAMIL NADU
627015
India |
| Phone |
9994619957 |
| Fax |
|
| Email |
deepthimds@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Angeline Deepthi |
| Designation |
Professor and Head of the department |
| Affiliation |
Rajas dental college and hospital |
| Address |
Department of oral medicine and radiology,
Ground floor,
Room No: 1,
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli
Tirunelveli
TAMIL NADU
627015
India |
| Phone |
9994619957 |
| Fax |
|
| Email |
deepthimds@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of oral medicine and radiology,
Ground floor,
Room No: 1,
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Rajas dental college and hospital |
| Address |
Department of oral medicine and radiology,
Ground floor,
Room No: 1,
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli |
| 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 Vishalini |
Rajas dental college and hospital |
Department of oral medicine and radiology,
Ground floor,
Room No: 1
Rajas dental college and hospital, Kavalkinaru junction, Tirunelveli
Tirunelveli
TAMIL NADU |
9363621529
vishalinikalaivanan98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics review board, Rajas dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TENS and LLLT |
ACUTENS machine will be used for TENS therapy for the duration of 20 minutes
DENLASE will be used for Low level laser therapy (3 cycles for 30 secs with a interval of 5 mins). |
| Intervention |
TENS and LLLT |
ACUTENS machine will be used for TENS therapy for the duration of 20 minutes
DENLASE will be used for Low level laser therapy (3 cycles for 30 secs with a interval of 5 mins). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with TMJ symptoms of both gender aged between 18 to 60 years.
Pain on both sides of TMJ
Group III of RDC criteria |
|
| ExclusionCriteria |
| Details |
Patient taking medications for TMD
Patient with pain on one side of TMJ
Group III of RDC criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain reduction in the TMJ region and muscles of mastication |
Outcome will be evaluated on Baseline, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 and Day 17 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mouth opening
Muscle tenderness |
Outcomes will be evaluated on Baseline, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 15 & Day 17 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| 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="0"
Months="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- 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 [vishalinikalaivanan98@gmail.com].
- For how long will this data be available start date provided 09-01-2024 and end date provided 15-03-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Temporomandibular joint disorder is a common presenting condition in the dental clinic. There are various treatment modalities for the management of TMD. No specific therapy has proven its superiority over other therapies. Hence, we compared the effectiveness of transcutaneous electric nerve stimulation (TENS) and Low level laser therapy (LLLT) in this study. The aim of the study is to compare and evaluate the effectiveness of transcutaneous electric nerve stimulation (TENS) and Low level laser therapy (LLLT) in the treatment of TMD. Ten patients with temporomandibular joint disorder are included in the study. The study will be done based on split mouth technique, in that TENS will be performed in one side of the TMJ (ACUTENS- frequency of 75 Hz and pulse width of 200 ms, and the intensity ranges between 20 to 25 watt/ m² for 20 minutes )and the LLLT will be performed in the another side of the TMJ (DENLASE- wavelength of 980 nm, energy ranges between 50 to 105 J/ cm², frequency of 10 KHz, power of 1.5 watt was used). Both the therapies will be planned to perform in total of 9 sessions in alternative days. Pain intensity was measured using VAS for each session and recorded. |