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CTRI Number  CTRI/2023/06/054163 [Registered on: 20/06/2023] Trial Registered Prospectively
Last Modified On: 13/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Movement of upper back teeth while supporting the backward movement of front teeth 
Scientific Title of Study   COMPARATIVE EVALUATION OF ANCHORAGE LOSS BETWEEN ACTIVE TIE BACKS AND COIL SPRINGS DURING ENMASSE RETRACTION IN BIMAXILLARY PROTRUSION CASES 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SHRINGA AMRITHESHWARI K N 
Designation  POST GRADUATE STUDENT 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  ROOM NUMBER 6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS CIDS KK CAMPUS VIRAJPET

Kodagu
KARNATAKA
571218
India 
Phone  9449783063  
Fax    
Email  shringa181@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR GOUTHAM B 
Designation  PROFFESOR AND HOD 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  ROOM NUMBER 6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS CIDS KK CAMPUS VIRAJPET

Kodagu
KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR GOUTHAM B 
Designation  PROFFESOR AND HOD 
Affiliation  COORG INSTITUTE OF DENTAL SCIENCES 
Address  ROOM NUMBER 6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS CIDS KK CAMPUS VIRAJPET


KARNATAKA
571218
India 
Phone  9900620536  
Fax    
Email  drgouthamreddy2000@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR SHRINGA AMRITHESHWARI K N 
Address  ROOM NUMBER 6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS CIDS KK CAMPUS VIRAJPET 
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 SHRINGA AMRITHESHWARI K N  COORG INSTITUTE OF DENTAL SCIENCES  ROOM NO:6 DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPEDICS CIDS KK CAMPUS VIRAJPET
Kodagu
KARNATAKA 
9449783063

shringa181@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
COORG INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARISON OF ANCHORAGE LOSS IN MOLARS BETWEEN ACTIVE TIEBACK AND COIL SPRING RETRACTION  COMPARISON OF ANCHORAGE LOSS IN MOLARS BETWEEN ACTIVE TIEBACK AND COIL SPRING RETRACTION USING PRE AND POST RETRACTION LATERAL CEPHALOGRAMS AFTER 6 MONTHS 
Intervention  RETRACTION USING COIL SPRING  RETRACTION USING COIL SPRING IN BIMAXILLARY CASES FOR 6 MONTHS 
Intervention  RETRACTION USING TIEBACK  USE OF ACTIVE TIEBACKS FOR RETRACTION IN BIMAXILLARY CASES FOR 6 MONTHS 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Minimal or no crowding
2. First premolar extraction cases
3. Low or average anchorage
 
 
ExclusionCriteria 
Details  1. Periodontally compromised cases.
2. Medically compromised patients
3. Severe crowded teeth
4. High anchorage cases
5. Missing molars
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
CLOSURE OF EXTRACTED SPACE  1 MONTH AND 6 MONTH 
 
Secondary Outcome  
Outcome  TimePoints 
LOSS OF ANCHORAGE  0 MONTH, 6 MONTHS 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   10/07/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 Tooth movement during orthodontic therapy is brought about by forces generated by the active components of an orthodontic appliance. The force used to move teeth is derived from certain anatomic areas which act as anchors.  Anchorage is defined as the resistance to unwanted tooth movement or as a desired reaction of posterior teeth to space closure mechanotherapy (1)

Graber has defined anchorage in orthodontics as the nature and degree of resistance to displacement offered by an anatomic unit for the purpose of effecting tooth movement.

Depending on the requirement, it can be classified as maximum anchorage(type A) , moderate anchorage (type B) and minimum anchorage units ( type C). (1)

According to Newton’s third law of motion , for every action there is an equal and opposite reaction. In accordance with this law , the forces used to move teeth may induce an equal and opposite force on the anchorage unit , tending to cause their movement.

Anchorage loss therefore is a reciprocal reaction that could obstruct the success of orthodontic treatment by complicating the anteroposterior correction of the malocclusion and possibly detracting from facial esthetics. (2)

Along the course of this study we intend to measure the anchorage loss in the maxillary first molar (anchorage unit) in bimaxillary cases where en-masse anterior retraction is done using conventional retraction techniques.

 

 

 
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