| CTRI Number |
CTRI/2024/12/077788 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
01/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of efficacy of therapeutic ultrasound in management of jaw pain of muscular origin |
|
Scientific Title of Study
|
Evaluation of efficacy of Therapeutic ultrasound modality in management of patients with Temporomandibular Disorders [TMDS] of muscular origin |
| 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 M Subhikshaa |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral Medicine and Radiology,
Room no -1,
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903434873 |
| Fax |
|
| Email |
subhikshaagrg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima Shetty |
| Designation |
Additional Professor |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral medicine and Radiology,
Room No-1,
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903434873 |
| Fax |
|
| Email |
Prathimaomr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Subhikshaa |
| Designation |
Post graduate resident |
| Affiliation |
Yenepoya Dental College |
| Address |
Department of Oral Medicine and Radiology,
Room no-1,
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8903434873 |
| Fax |
|
| Email |
subhikshaagrg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral Medicine and Radiology,
Room no-1,
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018.
|
|
|
Primary Sponsor
|
| Name |
Dr M Subhikshaa |
| Address |
Department of Oral medicine and Radiology,
Room no-1,
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018. |
| 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 M Subhikshaa |
Yenepoya Dental College |
Department of Oral medicine and Radiology,
Room no-1
Yenepoya Dental College,
Derlakatte,
Dakshina Kannada,
Karnataka-575018
Dakshina Kannada
KARNATAKA |
8903434873
subhikshaagrg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committee-I[YEC-I] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K08||Other disorders of teeth and supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Analgesics and Muscle relaxant |
7 Days |
| Intervention |
Therapeutic Ultrasound |
Therapeutic Ultrasound for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes Group 1 of RDC criteria of TMD which is muscle disorders-myofascial pain and myofascial pain with limited opening. |
|
| ExclusionCriteria |
| Details |
Patients with history of
Acute trauma and fracture
Orofacial infection
Skin lesion
Pregnant women
Benign and malignant lesion of TMJ
Cardiac pacemakers and arrythmias
Kidney diseases
Allergy to acoustic gel
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain reduction
Increase in mouth opening |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sustained pain
Restricted mouth opening |
7 days |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
15/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Temporomandibular disorders [TMDs] is one of the most common causes of orofacial pain which often causes chronic pain. It affects temporomandibular joint [TMJ], muscles of mastication and associated structures. Therapeutic ultrasound is a non-invasive physical method, which penetrates deep into tissues, produce heat improves blood flow and accelerates healing and it is more effective in muscles hence this study is to evaluate efficacy of Therapeutic ultrasound modality in the management of pain in patients with Temporomandibular disorders [TMDs] of muscular origin. |