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CTRI Number  CTRI/2021/03/032415 [Registered on: 30/03/2021] Trial Registered Prospectively
Last Modified On: 26/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Comparison of muscle relaxing ability of two appliances used for bite recording  
Scientific Title of Study   Masticatory muscle activity in normal individuals using two types of anterior deprogrammers – A Randomized Clinical Trial. 
Trial Acronym  ANT DEPRG 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Eazhil Rajamony  
Designation  Professor 
Affiliation  Chettinad Dental College and Research Institute 
Address  Department of Prosthodontics, E Block, 3rd Floor, Room No.7, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9841332224  
Fax    
Email  eazhil235@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jagdish Sivanesan Karthikeyan 
Designation  Reader 
Affiliation  Chettinad Dental College and Research Institute 
Address  Department of Prosthodontics, E Block, 3rd Floor, Room No.7, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9940163850  
Fax    
Email  jagdishsk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jagdish Sivanesan Karthikeyan 
Designation  Reader 
Affiliation  Chettinad Dental College and Research Institute 
Address  Department of Prosthodontics, E Block, 3rd Floor, Room No.7, Chettinad Dental College and Research Institute, Rajiv Gandhi Salai, Kelambakkam

Kancheepuram
TAMIL NADU
603103
India 
Phone  9940163850  
Fax    
Email  jagdishsk@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiology, Chettinad Medical College and Hospital, Kelambakkam - for EMG recording and interpretation 
Department of Prosthodontics, Chettinad Dental College and Research Institute, Kelambakkam - as principal center of investigation and materials support 
 
Primary Sponsor  
Name  Sivanesan Karthikeyan Jagdish 
Address  Department of Prosthodontics, Chettinad Dental College and Research Institute 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
None  none 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Eazhil R  Chettinad Dental College and Research Institute, Kelambakkam  Department of Prosthodontics, E Block, 3rd floor, Room No.7, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram
TAMIL NADU 		 9841332224

eazhil235@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy volunteers with normal temporomandibular joint and Helkimo index of zero 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Kois Deprogrammer  It is an alternative appliance which is used to record bite of individuals by relaxing the jaw muscles. 
Intervention  Lucia Jig Anterior Deprogrammer  It is a conventional appliance which is used to record the bite of individuals by relaxing the jaw muscles. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Healthy individuals
2. Male and female from age group of 18 years to 40 years.
3. Clinically symptom free for TMJ dysfunction (with Helkimo’s dysfunction index 0)
 
 
ExclusionCriteria 
Details  1. Individuals under orthodontic treatment
2. TMJ or myofacial pain / Disorders
3. Patients with bruxism or other parafunctional habits
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Muscle activity of right and left Masseter and Temporalis using surface Electromyography  Baseline (before insertion of appliance), 30 min after insertion of the appliance or after complete deprogramming is achieved - whichever is earlier 
 
Secondary Outcome  
Outcome  TimePoints 
Pain/ discomfort in TMJ/ Muscles  30 min after insertion of appliance 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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   Phase 4 
Date of First Enrollment (India)   01/04/2021 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 -  Study Protocol
    Response -  Statistical Analysis Plan
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [jagdishsk@gmail.com].

  6. For how long will this data be available start date provided 01-01-2022 and end date provided 31-01-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

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

Clinical procedures:

Maxillary and mandibular impressions will be made for all the participants using Alginate impression material and the respective casts will be obtained. The casts will be articulated in maximal intercuspation on an articulator. Lucia Jig and Kois deprogrammer will be fabricated on the dental casts using self-cure acrylic material using standard protocols. Each participant will be allotted to the respective intervention groups as described previously.

Baseline activity of muscles (EMG) temporalis and masseter will be determined before insertion of the deprogrammers. Volunteers will be randomly given two types of deprogrammers - Lucia Jig and the Kois Deprogrammer. Deprogramming will be done for 30 minutes or till the time the volunteers give a precise centric point using an articulating paper.After deprogramming, the EMG activities of temporalis and masseter will be assessed again and recorded.

After a wash-out period of 1 week the volunteers will be allotted to the second intervention. Again, the volunteers’ base line muscle activity will be recorded, before the intervention. After insertion of the appliance, deprogramming will be done as described earlier and the muscle activities will be recorded.

 
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