| CTRI Number |
CTRI/2024/06/068846 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing Ultrasound, Laser and TENS for pain management of the jaw in patients after prolonged mouth opening |
|
Scientific Title of Study
|
Comparative Evaluation of efficacy of Therapeutic Ultrasound, TENS and LLLT in management of TMJ pain in patients following Restorative procedure: A Randomized Clinical 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 |
Aishwarya Jain |
| Designation |
Post graduate |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room number 8, Dept of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Piparia, Vadodara - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
07709072979 |
| Fax |
|
| Email |
aishwaryaj34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nimisha Shah |
| Designation |
HOD, Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room number 8, Dept of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Piparia, Vadodara - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nimisha Shah |
| Designation |
HOD, Professor |
| Affiliation |
KM Shah Dental College and Hospital |
| Address |
Room number 8, Dept of Conservative Centistry and Endodontics, Sumandeep Vidyapeeth, Piparia, Vadodara - 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9998994299 |
| Fax |
|
| Email |
nshah7873@gmail.com |
|
|
Source of Monetary or Material Support
|
| K.M Shah dental college and hospital, Sumandeep vidyapeeth university |
|
|
Primary Sponsor
|
| Name |
Aishwarya Jain |
| Address |
Room number 8, Dept of Conservative Dentistry and Endodontics, Sumandeep Vidyapeeth, Piparia, Vadodara - 391760 |
| 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 Nimisha Shah |
K. M shah dental college and hospital, Sumandeep vidyapeeth university |
Room number 8, Dept of Conservative Dentistry and Endodontics
Vadodara
GUJARAT |
9998994299
nshah7873@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Low level laser therapy (Epic 10. Biolase) |
940nm wavelength diode laser. The application will be done by the principal investigator at the TMJ musculature region with the laser set at ‘pain therapy’ mode and activated at 4.0 W for 10-15 minutes at each side depending on the heat threshold of patient. |
| Intervention |
Therapeutic Ultrasound device |
Patients will be given therapy at 1MHz frequency, with a transuder head of 5cm and an effective radiating area of 5cm2 + 20%, placing the probe in TMJ region for 10-15 minutes each side depending on the threshold of the patientimmediately after therapy, after 6 hours, after 24 hours and after 48 hours.
|
| Comparator Agent |
Transcutaneous nerve stimulation device(Ultracare-Pro TENS 2.0) |
Ultracare-Pro TENS 2.0 unit will be placed at the level of TMJ at a setting of 2-200 Hz frequency, 15 minutes session on each side at 1-10 mode and therapy will be given depending on the threshold of the patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having a TMJ pain of VAS more than 3 on 1 to 10 point scale on mouth opening following the restorative treatment will be included in the study. Patients requiring the placement of rubber dam for restorative treatment will be included in the study. A written informed consent will be taken from all the patients and only those patients ready to sign the consent form will be included in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients with myocardial disorders having pacemakers, recent trauma and epileptic patients will be excluded from the study
2. Patients with pulpal exposure will be excluded for the study.
3. Patients with TMD pain prior to the treatment will be excluded from the study
4. Patients who had taken analgesic medication 12 hrs before the treatment will be excluded from the study 5.Pregnant and lactating women will be excluded.
6.Medically compromised patients and patients with history to any substance abuse
will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare efficacy of Therapeutic Ultrasound, TENS and LLLT in management of TMJ pain in patients following Restorative procedure immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
|
immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| will tell us about which technique is better for TMJ pain management |
immediately after therapy, after 6 hours, after 24 hours and after 48 hours.
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
07/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| 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 - NO
|
|
Brief Summary
|
-
-
Patients with post-restorative procedures will be further assessed for evaluation of pain after removal of rubber dam using VAS. Patient with VAS scale of > 3 will be further subjected for the therapy. In Therapeutic ultrasound group patients, will be given therapy at 1MHz
frequency, with a transuder head of 5cm and an effective radiating area of
5cm2 + 20%, placing the probe in TMJ region for 10-15 minutes each side depending on the threshold of the patient. In TENS group, Ultracare-Pro TENS 2.0 unit will be placed at the level of TMJ at a setting of 2-200 Hz frequency, 15 minutes session on each side at 1-10 mode and therapy will be given depending on the threshold of the patients. Patient will be explained about VAS scale, and the pre-treatment VAS scale
readings will be recorded. 
In LLLT group, therapy will be performed using 940nm wavelength diode laser
(Epic 10. Biolase). The application will be done by the principal investigator
at the TMJ musculature region with the laser set at ‘pain therapy’ mode and
activated at 4.0 W for 10-15 minutes at each side depending on the heat threshold of patient. The co-investigator will then assess the pain, immediately after the therapy
using VAS (1-10 point) scale. Later the pain will be assessed by the co-
investigator immediately after therapy, at 6 hours, at 24 hours and at 48 hours. If pain still persists, then analgesics will be given and patient will be excluded from the study
|