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CTRI Number  CTRI/2024/08/071985 [Registered on: 06/08/2024] Trial Registered Prospectively
Last Modified On: 07/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Binaural Beats for the treatment of TMJ Disorder in Dental Students 
Scientific Title of Study   Efficacy of binaural beats in treatment of TMJ disorders 
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 Anuradha yadav 
Designation  Associate professor  
Affiliation  ITS centre for dental studies and research Ghaziabad 
Address  Oral medicine and radiology department,room no.1,ITS centre for dental studies and research
Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9717789413  
Fax    
Email  annuudentalcare011@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kalash Gupta 
Designation  BDS  
Affiliation  ITS centre for dental studies and research Ghaziabad 
Address  ITS centre for dental studies and research
Muradnagar, Ghaziabad, Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9873877372  
Fax    
Email  kalashgupta04@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuradha yadav 
Designation  Associate professor 
Affiliation  ITS centre for dental studies and research Ghaziabad 
Address  Oral medicine and radiology department,room no. 1, ITS centre for dental studies and research
Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India 
Phone  9717789413  
Fax    
Email  annuudentalcare011@gmail.com  
 
Source of Monetary or Material Support  
ITS centre for dental studies and research, Muradnagar, Ghaziabad, Uttar Pradesh, 201206 
 
Primary Sponsor  
Name  Dr. Anuradha yadav 
Address  Oral medicine and radiology department, ITS centre for dental studies and research  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Anuradha yadav  ITS centre for dental studies and research   Deparment of oral medicine and radiology, Room no. 1 ,ITS centre for dental studies and research center ,Muaradnagar,Ghaziabad,Uttar pradesh,201206
Ghaziabad
UTTAR PRADESH 		 9717789413

annuudentalcare011@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
I.T.S INSTITUTIONAL ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ultrasound therapy  Ultrasound therapy will be given at 3MHz for 3 days 
Intervention  Ultrasound therapy for tmj and binaural auditory beats   Ultrasound therapy will be given at 3MHz for 3 days with consecutive 5 days of Binaural beats for 5 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  TMJ pain, stiffness, or related symptoms 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
binaural beats will be more successful in lowering anxiety and pain   1 week 
 
Secondary Outcome  
Outcome  TimePoints 
binaural beats can be one of the therapeutic alternative   1 week 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/08/2024 
Date of Study Completion (India) 31/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="8" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Yadav A , Gupta K , Doliya K , Rathore A , Efficacy of binaural beats in the treatment of TMJ disorders: A randomized control trial. J Dent Spec 2025;13(1):88-92  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 09-08-2024 and end date provided 30-09-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This study is a randomized clinical controlled trial to be carried out in the Department of Oral Medicine and Radiology at ITS Dental College, Ghaziabad. The experimental group will be receiving treatment with both ultrasound therapy and binaural auditory beats, while the control group’s participants will receive simply ultrasound therapy without any music intervention. Ultrasound therapy will be given at 3MHz for 3 days in both groups with consecutive 5 days of Binaural beats for 5 minutes in the experimental group. The outcomes will be checked after 1 week in both groups.

 
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