| CTRI Number |
CTRI/2022/09/045376 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Masseter muscle hardness by elastography in muscle pain |
|
Scientific Title of Study
|
Comparative Evaluation of Masseter Muscle stiffness by Muscle hardness meter and Ultrasound elastography in patients with Temporomandibular disorders -A case control study |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Jatti Patil |
| Designation |
Associate Professor |
| Affiliation |
Sumandeep Vidyapeeth Deemed to be University |
| Address |
Dept of Oral Medicine and Radiology
KM Shah Dental College and Hospital
Sumandeep Vidyapeeth Deemed to be University
Piparia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7626363934 |
| Fax |
|
| Email |
iafdeepa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh kumar Rathore |
| Designation |
Professor |
| Affiliation |
Sumandeep Vidyapeeth Deemed to be University |
| Address |
Dept of Radiology
S B.KS Medical Institute and Researcg centre
Sumandeep Vidyapeeth Deemed to be University
Piparia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
|
| Fax |
9327249686 |
| Email |
rajeshrathore26rj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Jatti Patil |
| Designation |
Associate Professor |
| Affiliation |
Sumandeep Vidyapeeth Deemed to be University |
| Address |
Dept of Oral Medicine and Radiology
KM Shah Dental College and Hospital
Sumandeep Vidyapeeth Deemed to be University
Piparia
Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7696263934 |
| Fax |
|
| Email |
iafdeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Radiology, SB KS MI and RC institute,Sumandeep Vidyapeeth Deemed to be University,Vadodara |
|
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Primary Sponsor
|
| Name |
Deepa Jatti Patil |
| Address |
Department of Oral Medicine and Radiology, KM Shah Dental College and Hospital,Vadodara |
| Type of Sponsor |
Other [Self for PhD research] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepa Jatti Patil |
SBKS Medical Institute and Research Centre |
Department of Radiology, Dhiraj Hospital
Sumandeep Vidyapeeth Deemed to be University
Piparia, Vadodara
Vadodara
GUJARAT |
7696263934
iafdeepa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult Healthy patiients with no history of Temporomandibular disorders or clicking or muscle pain |
| Patients |
(1) ICD-10 Condition: M266||Temporomandibular joint disorders, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The Diagnostic Criteria for Temporomandibular disorders (DC/TMD) Axis I will be used for the classification
2. Patients with Myofascial pain will be included in the study.
3. Both male and female patients aged between 18 to 50 years will be included in the study
4. Healthy controls comprising of 80 adult healthy volunteers (age, 18–50 years) with normal teeth and jaws, who will not be classified into groups I/II/III by DC/TMD, with no history of jaw movement dysfunction, pain in the temporomandibular joint, abnormalities in mouth opening, trauma or surgery involving TMJ over the previous 3 months and who agree to participate in this study
|
|
| ExclusionCriteria |
| Details |
1.Participants who refused to give a written consent will be excluded from
the study.
2.Terminally ill patients or patients with chronic morbidity will be excluded.
3.Patients with neurological diseases like stroke, cerebral palsy and parkinsonism.
4.Patients with pregnancy, bone diseases, systemic diseases, cancer, acute pain, a history of drug ingestion within the past week (e.g., analgesics, muscle relaxants and anti-inflammatory drugs)
5.Patients with psychiatric morbidities or patients on an antipsychotic medication
6.Patients with restricted mouth opening because of odontogenic infections
7.Participants with severe illness, unable to communicate, lunatic and uncooperative patients will be excluded from the study.
8.Participants with history of head and neck trauma and Ototoxicity.
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Method of Generating Random Sequence
|
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Method of Concealment
|
|
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Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of hardness values of Masseter Muscle in patients with Temporomandibular disorders and healthy controls |
1 month and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation between Masseter Muscle pain in patients with Temporomandibular disorders
Correlation with Masseter muscle thickness and muscle hardness
with masseter muscle hardness values. |
1 month, 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
15/09/2022 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This is a case-control study to evaluate and compare muscle hardness in patients with temporomandibular disorders and adult healthy volunteers. The sample size of the study is 160,80
cases and 80 controls.
The cases will include patients with Temporomandibular disorders who will be diagnosed based on DC/TMD criteria. The controls will be healthy adult volunteers
with no history of trauma or Temporomandibular joint pain. A detailed clinical and extraoral examination of the Temporomandibular joint will be performed and recorded on a case history proforma. The visual analog scale values will be recorded for muscle pain. The masseter muscle hardness will be measured by a muscle hardness meter and the values will be recorded.
The same patients will be subjected to Ultrasound elastography and the muscle stiffness values will be recorded on an elastogram on right and left sides. The thickness of the masseter
muscle will be assessed by USG bilaterally.
The primary outcome measures will be assessing the muscle hardness values in healthy patients and patients with Temporomandibular disorders. The secondary outcome measures will be correlating visual analog scale values with muscle stiffness and correlating masseter muscle thickness with muscle stiffness values obtained by using muscle hardness meter and USG Elastography and muscle hardness meter.
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