| CTRI Number |
CTRI/2021/10/037490 [Registered on: 22/10/2021] Trial Registered Prospectively |
| Last Modified On: |
20/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of jaw exercises with ultrasound to manage jaw pain |
|
Scientific Title of Study
|
Effectiveness of isometric exercises with therapeutic ultrasound in temporomandibular joint disorders- A Randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kripa Adlene Edith A |
| Designation |
Post Graduate student |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad,
Mangalore-575001,
Karnataka
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad,
Mangalore-575001,
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8903431657 |
| Fax |
|
| Email |
edithkripa3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ravikiran Ongole |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad,
Mangalore-575001,
Karnataka
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad,
Mangalore-575001,
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448430387 |
| Fax |
|
| Email |
ravikiran.ongole@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ravikiran Ongole |
| Designation |
Professor and Head |
| Affiliation |
Manipal College of Dental Sciences, Mangalore |
| Address |
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad
Mangalore-575001,
Karnataka
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthouse Hillroad,
Mangalore-575001,
Karnataka
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448430387 |
| Fax |
|
| Email |
ravikiran.ongole@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences, Mangalore |
|
|
Primary Sponsor
|
| Name |
Manipal College of Dental Sciences Mangalore |
| Address |
Manipal College of Dental Sciences,
Lighthouse Hillroad
Mangalore- 575001
Karnataka |
| Type of Sponsor |
Private medical 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 |
| Kripa Adlene Edith |
Manipal College of Dental Scieces, Mangalore |
Department of Oral Medicine and Radiology,
Room No.1,
Manipal College of Dental Sciences,
Lighthose Hill Road
Mangalore-575001
Karnataka
Dakshina Kannada
KARNATAKA |
8838361997
edithkripa3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Manipal College Of |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U07-U07||Provisional assignment of new diseases of uncertain etiology or emergency use, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Isometric Exercises |
The isometric exercises as per Pertes and Gross will be demonstrated to the patient. Patient will be advised to perform these exercises at least for a period of 6 months |
| Comparator Agent |
Therapeutic Ultrasound with Isometric exercises |
Therapeutic ultrasound will be delivered once a week for a period of one month. Based on the nature of the pain (acute/ chronic) ultrasound will be delivered either in a pulsed mode for acute pain and in a continuous mode for chronic pain.
3MHz frequency will be chosen for pain originating from superficial tissues and 1 MHz will be chosen on deep tissues.
The intensity will be varied according to the tolerance to treatment by the patient. |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of TMD was made based upon research diagnostic criteria (RDC) for clinical TMDs conditions. Group Ia and b (RDC/TMD Group Ia and b) and clinical diagnostic criteria for TMDs (Myalgia and Myofascial pain dysfunction) |
|
| ExclusionCriteria |
| Details |
1. Patients with trauma to TMJ
2. Patients with congenital abnormalities related to TMJ.
3. Patients suffering from odontogenic infections like abscesses, cysts, or any other periapical pathology swelling.
4. Any pre- or post-surgical complications about TMJ.
5. Any metastatic tumors, cysts, or carcinomas of the oral cavity to the TMJ.
6. Patients with neurological disturbances (such as cerebral palsy, movement disorder, speech and language disorder).
7. Patients undergoing orthodontic treatment.
8. Patients under analgesics and muscle relaxants.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
subjective evaluation of TMJ pain using VAS ( pain at rest and motion).
|
The VAS for pain will be measured at baseline and at first week, second week, third week, fourth week after administering therapeutic ultrasound.
the VAS for pain will be measured at baseline, at the end of 1 month and at the end of six months after performing isometric exercises |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Range of motion and Mouth opening |
Mouth opening and range of motion will be measured at basleline and at first week, second week, third week, fourth week after administering therapeutic ultrasound.
Mouth opening and range of motion will be measured at baseline, at the end of one month and six months after performing isometric exercises. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2021 |
| 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
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TMDs are managed through various ways such as dental rehabilitation, splint therapy, cognitive-behavioral therapy (CBT), pharmacotherapy, surgical approach, physiotherapy, massage therapy, therapeutic ultrasonography, short wave diathermy. Amongst these modalities, therapeutic ultrasound has gained wide acceptance along with conventional physical methods such as physiotherapy. Hence in our study, we plan to assess and compare the effectiveness of isometric exercises and therapeutic ultrasound. In this study, we will assess pain relief ( visual analog scale for pain) in TMJ before and after isometric exercises and Therapeutic Ultrasound, lateral excursion of the mandible before and after Isometric exercises, and Therapeutic Ultrasonography, assess mouth opening (inter incisal distance) before and after Isometric exercises and Therapeutic Ultrasonography |