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
|
|
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
|
|
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
|
|
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.
|