| CTRI Number |
CTRI/2020/05/025016 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
02/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the outcome of Damon and MBT prescription. |
|
Scientific Title of Study
|
Clinical efficiency of Damon and MBT prescriptions:A prospective comparative study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moushomi Paul |
| Designation |
Post-Graduate Student |
| Affiliation |
KLE Societys Institute Of Dental Sciences |
| Address |
KLE Societys Institute Of Dental Sciences.Yeshwantpur suburb,Tumkur Main Road.Bengaluru
Department of Orthodontics Room no.7 22,Yeshwantpur suburb,Tumkur Main Road,Bengaluru,Karnataka 560022
Tumkur
KARNATAKA
560022
India |
| Phone |
9901532975 |
| Fax |
|
| Email |
moushomipaul@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAravind M |
| Designation |
Reader |
| Affiliation |
KLE Societys Institute Of Dental Sciences |
| Address |
KLE societys institute of dental sciences.Yeshwantpur suburb,Tumkur Main Road.Bengaluru
Department of Orthodontics Room no.7 22,Yeshwantpur suburb,Tumkur Main Road,Bengaluru,Karnataka 560022
Tumkur
KARNATAKA
560022
India |
| Phone |
9886111436 |
| Fax |
|
| Email |
aravindorthodoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Moushomi Paul |
| Designation |
Post-Graduate Student |
| Affiliation |
KLE Societys Institute Of Dental Sciences |
| Address |
KLE Societys Institute Of Dental sciences.Yeshwantpur suburb,Tumkur Main Road.Bengaluru
Department of Orthodontics Room no.7 22,Yeshwantpur suburb,Tumkur Main Road,Bengaluru,Karnataka 560022
Tumkur
KARNATAKA
560022
India |
| Phone |
9901532975 |
| Fax |
|
| Email |
moushomipaul@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Dr.Moushomi paul.Rani Chenamma girls hostel,KLE societys institute of dental sciences.Yeshwantpur suburb,Tumkur Main Road.Bengaluru.560022 |
|
|
Primary Sponsor
|
| Name |
Moushomi Paul |
| Address |
Rani Chenamma girls hostel,KLE societys institute of dental sciences.Yeshwantpur suburb,Tumkur Main Road.Bengaluru |
| Type of Sponsor |
Other [Self-sponsored] |
|
|
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 |
| Moushomi Paul |
KLE Societys Institute of Dental Sciences |
Department of Orthodontics Room no.7 22,Yeshwantpur suburb,Tumkur Main Road,Bengaluru,Karnataka 560022
Tumkur
KARNATAKA |
9901532975
moushomipaul@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z008||Encounter for other general examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Damon self ligating appliance. |
Appliance will be used for 1 to 2 years for orthodontic teeth alignment. |
| Comparator Agent |
MBT appliance. |
Appliance is used for 1 to 2 years for orthodontic teeth alignment. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Non extraction cases
2. Mild to moderate crowding or spacing
3. No history of previous orthodontic treatment
4. Fully erupted permanent dentition excluding third molars
|
|
| ExclusionCriteria |
| Details |
Congenitally missing teeth
2.Orthopedic expansion
3.Skeletal anchorage
4.Prosthetically rehabilitated patients
5. Periodontally compromised patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in inclination of teeth in degrees in terms of tip and torque values.Anchor loss values in millimetres. |
Change in inclination of teeth in degrees in terms of tip and torque values.Anchor loss values in millimetres IN 24 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expansion of arches in millimetres. |
24months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
05/05/2020 |
| 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="2"
Months="0"
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)?
|
|
Brief Summary
|
There have been studies where tip and torque values,arch width dimension and anchor loss caused by the MBT and Damon appliances have been done separately but no study have been done comparing the prescription of these two appliances, of which gives better treatment outcomes in terms of above mentioned parameters.And further the vertical and sagittal changes correlation would be expressed in terms of a ratio.The result of this study would enable patients to decide patient on choosing the appliance for the treatment. |