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CTRI Number  CTRI/2024/10/074999 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prevalence of craniofacial trigger points and myogenic temporomandibular disorder  
Scientific Title of Study   Prevalence of craniofacial trigger points and myogenic temporomandibular disorder a cross sectional 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  S Amos M Sundaraj  
Designation  Master of physiotherapy student  
Affiliation  Institute of Physiotherapy, Srinivas University  
Address  Departmant of physiotherapy, srinivas University, pandeshwar, Mangalore dakshina Kannada
Department of physiotherapy, srinivas University, pandeshwar, Mangalore dakshina Kannada
Dakshina Kannada
KARNATAKA
575001
India 
Phone  8369062850  
Fax    
Email  amossundaraj99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Ajay kumar  
Designation  Professor  
Affiliation  Institute of Physiotherapy, Srinivas University  
Address  Departmant of physiotherapy, srinivas University, pandeshwar campus, Mangalore dakshina Kannada
Department of physiotherapy, srinivas University, pandeshwar, Mangalore dakshina Kannada
Dakshina Kannada
KARNATAKA
575001
India 
Phone  7019238290  
Fax    
Email  drajay@srinivasuniversity.edu.in  
 
Details of Contact Person
Public Query  
Name  S Amos M Sundaraj  
Designation  Master of physiotherapy student  
Affiliation  Institute of Physiotherapy, Srinivas University  
Address  Departmant of physiotherapy, srinivas University, pandeshwar, Mangalore dakshina Kannada
Department of physiotherapy, srinivas University, pandeshwar, Mangalore dakshina Kannada
Dakshina Kannada
KARNATAKA
575001
India 
Phone  8369062850  
Fax    
Email  amossundaraj99@gmail.com  
 
Source of Monetary or Material Support  
Srinivas institute of dental science srinivas nagar mukka suratkal mangaluru Karnataka 575021 India 
 
Primary Sponsor  
Name  S Amos M Sundaraj  
Address  Departmentof physiotherapy, srinivas University, pandeshwar campus Mangalore dakshina Kannada Karnataka 575001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
N   
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr S Amos M Sundaraj   Institute of physiotherapy ,srinivas University   Department of Physiotherapy Institute of physiotherapy, srinivas University, pandeshwar campus Mangalore dakshina Kannada Karnataka
Dakshina Kannada
KARNATAKA 		 8369062850

amossundaraj99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Srinivas University ethics committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M266||Temporomandibular joint disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Referred from dental clinics as orofacial pain including masticator muscle spasm or bruxism
18 to 50 years both genders
History of periaurcular pain with or without joint sound for at least 3 months
 
 
ExclusionCriteria 
Details  Hyperplasia, hypoplasia5
Rheumatoid arthritis
Bone ankylosis
Other painful TMD disorder
Primary headaches
Fibromyalgia14
TMJ disk click
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analogue scale(VAS)  Baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Visual analogue scale   1st day after 4 weeks 
 
Target Sample Size   Total Sample Size="97"
Sample Size from India="97" 
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)   21/10/2024 
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="1"
Months="0"
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 - NO
Brief Summary   The aim of the study is to find out the prevalence and distribution of craniofacial trigger sites in people diagnosed with myogenic temporomandibular disorder
To find out the prevalence of craniofacial trigger points in temporalis, masseter, medial and lateral pterygoid muscle and myogenic temporomandibular disorder to enhance the understanding of potential contributing factor and effective treatment strategies.
 The possible causes and contributing factors of temporomandibular disorders (TMD)are important to investigate the incidence of craniofacial trigger sites in patients with myogenic TMD . Researchers will get a better understanding of the underlying mechanics by finding and evaluating trigger points in the craniofacial region. Additionally, it will help in developing more precise diagnostic techniques as well as more individualized treatment plans for those who are affected with myogenic TMD. Furthermore, by reducing the incidence and severity of TMD , the preventive methods could be developed with the use of this research to mitigate this disorder.
 
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