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CTRI Number  CTRI/2019/02/017585 [Registered on: 12/02/2019] Trial Registered Prospectively
Last Modified On: 10/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Neck muscle activity before and after giving appliance to bring lower jaw forward in patients with abnormal lower jaw 
Scientific Title of Study   Sternocleidomastoid and Trapezius muscle activity before and after Twin block therapy in skeletal Class II growing patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Gothankar Greeshma 
Designation  Junior Resident Acad 
Affiliation  AIIMS New Delhi 
Address  4th floor, Dental building ,Dept of Orthodontics , CDER, AIIMS ,Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9969374351  
Fax    
Email  gothankar1792@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Dr O P Kharbanda 
Designation  Professor and Head of Department 
Affiliation  AIIMS New Delhi 
Address  4th floor, Dental building ,Dept of Orthodontics , CDER, AIIMS ,Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9899062144  
Fax    
Email  opk15@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Gothankar Greeshma 
Designation  Junior Resident Acad 
Affiliation  AIIMS New Delhi 
Address  4th floor, Dental building ,Dept of Orthodontics , CDER, AIIMS ,Ansari Nagar, New Delhi-110029

New Delhi
DELHI
110029
India 
Phone  9969374351  
Fax    
Email  gothankar1792@gmail.com  
 
Source of Monetary or Material Support  
CDER, AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  4th floor, Dept of orthodontics, CDER,Ansari Nagar, AIIMS,New Delhi-110029 
Type of Sponsor  Government medical college 
 
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 
Prof Dr O P Kharbanda  AIIMS,New Delhi  4th floor Dental building, Dept of Orthodontics, CDER, AIIMS New Delhi-110029
New Delhi
DELHI 
9899062144

opk15@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics comittee for postgraduate research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  young growing skeletal Class II patients with Class II Div I malocclusion  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  1. Young growing patients diagnosed with skeletal class II malocclusion due to retrognathic mandible (indicated for Twin Block appliance)
2. Age group: 9-14 years
3. CVMI stage: CVMI stage 2 and 3
4. FMA angle: 20°-29° (Average growth pattern)
5. Gender: irrespective of gender
6. Willing informed consent
 
 
ExclusionCriteria 
Details  1. Patient with signs and symptoms of neuromuscular disorders or temporomandibular disorders.
2. Patient with any history of bruxism.
3. Patient with history of previous or current orthodontic treatment.
4. Compromised physical or mental health
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
there will be change in muscle activity of sternocleidomastoid and trapezius muscle activity after giving Twin Block therapy  0 month, 1 month , 3 month, 6 month and 9 month 
 
Secondary Outcome  
Outcome  TimePoints 
there will be advancement of mandible after givig Twin Block therapy  0 month, 1 month , 3 month, 6 month and 9 month 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 1 
Date of First Enrollment (India)   25/02/2019 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Aim:

The study is aimed to evaluate muscle activity of sternocleidomastoid and trapezius muscle following correction of skeletal class II malocclusion with Twin Block appliance.

 Objective:

To compare pre and post 9 months changes in sEMG activity of sternocleidomastoid and trapezius muscle during postural rest position of mandible , maximum voluntary clenching and side to side movement of neck in growing skeletal class II patients treated with Twin Block appliance.

A major objective of orthodontic treatment is the establishment of harmonious relation of dentoalveolar structures with each other and with the musculoskeletal system which surrounds it. Such relation should be functionally stable and aesthetically pleasing to patient.

Skeletal class II malocclusion is resultant of either excessive maxillary growth or due to retarded mandibular growth. Twin block appliance mainly helps in growth modification of mandible in forward direction and neuromuscular adaptation of adjacent muscles. There are evidences saying that integrity of craniocervical system may be significantly dependent on position of mandible. Mastication, speech and respiration are vitally dependent on adequate mandibular position. In addition, this is also required for correction of postural relationships with other parts of head and neck. The Twin block is able to reduce muscle tension not only in craniofacial region but also in cervical region. It is intraoral, robust and less bulky appliance. With this in mind the present study is aimed to evaluate muscle activity of sternocleidomastoid and trapezius muscle following correction of skeletal class II malocclusion with Twin Block appliance.


 
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