| 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
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
4th floor, Dept of orthodontics, CDER,Ansari Nagar, AIIMS,New Delhi-110029 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
|
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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
|
|
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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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