| CTRI Number |
CTRI/2020/05/025028 [Registered on: 05/05/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Dentistry |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
A clinical try to compare the changes in the tooth and bone position when using a new type of braces using very light forces and a conventional braces used for treating patients with irregular teeth-A 3 Dimensional study. |
|
Scientific Title of Study
|
Comparison of changes in the bone thickness,transverse arch dimensions and arch length between conventional brackets and the Passive self ligating brackets with different arch wire combinations using CBCT and Digital models |
| Trial Acronym |
DAPSL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Aravind Kumar |
| Designation |
Professor and Head |
| Affiliation |
Saveetha Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No 27,Saveetha Dental College and hospital,
163 Poonamalle high road
Vellpanchavadi,
Chennai PIN 600077
Tamil-Nadu
India.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9841299939 |
| Fax |
|
| Email |
dr.aravind.s@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish BabuS |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and HospitL |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No 27,Saveetha Dental College and hospital
163 Poonamalle High road,
Vellpanchavadi,
Chennai PIN 600077
Tamil-Nadu
India.
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9360575950 |
| Fax |
|
| Email |
harish.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwin Mathew George |
| Designation |
Professor |
| Affiliation |
Saveetha DentalCollege and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopedics, Room No 27,Saveetha Dental College and hospital,
163 Poonamalle high road,
Vellpanchavadi,
Chennai PIN 600077
Tamil-Nadu,
India.
163,Poonamalle High Road
Chennai-600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840032771 |
| Fax |
|
| Email |
ashwingeorge90@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ormco Asia |
| Address |
Ormco India ,C/O Nobel Biocare Pvt Ltd,Unit No 702,7th Floor,A Wing,Supreme Business Park,Supreme City,Powai,Mumbai,400076 |
| Type of Sponsor |
Other [Orthodontic appliances Distributor] |
|
|
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 Harish Babu |
Saveetha Dental College and Hospital |
Room no 27,Dept of Orthodontics,Post Graduate Division
Thiruvallur
TAMIL NADU |
9360575950
harish.ortho@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Saveetha Dental College and Hospitals Saveetha Institute of Medical and Technical Sciences |
Approved |
| Institutional Human Ethical CommitteeSaveetha Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z13||Persons encountering health services for examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Passive Self Ligating Brackets |
Damon Q Passive Self Ligating Brackets and Damon Broad Arch forms ,CuNiti wires.
Duration of therapy 18 months |
| Comparator Agent |
Standard MBT Bracket system |
Conventional Arch wires
Duration of Therapy:-18 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1.Non Extraction Orthodontic treatment with a space discrepancy more than 5mm.
2. Permanent dentition with full compliment of teeth excluding third molars.
3. No relevant medical history. |
|
| ExclusionCriteria |
| Details |
1. Mixed dentition.
2. Previous history of orthodontic treatment.
3. Tooth with developmental anomalies and fluorosis.
4. Restoration involving labial surface of tooth.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Alveolar Bone thickness |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Arch length and Arch width |
19 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
07/05/2020 |
| 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="1"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized single blinded controlled study which aims to evaluate and compare the effects of a passive self ligating appliance vs conventional fixed appliance wit broad and regular arch form when used to correct malocclusions. A total of 80 randomly selected orthodontic patients with malocclusions of crowding oF more than 5mm in an arch will be enrolled in this study. They will be divided into 4 groups of 20 patients each. Group 1-Control group using conventional brackets with regular arch forms. Group 2-Passive self ligating brackets with broad arch forms. Group 3-Passive self ligating with regular arch forms. Group 4-Conventional brackets with broad arch forms.
All the patients are subjected to orthodontic diagnostic aids comprising of a Cone Beam Cone Beam Computed tomography(CBCT) and Digital Models. Patients were recalled for treatment according to specific group protocols and the arch wire changes were made. At the completion of treatment the patients were subjected to another set of CBCT and Digital models .The outcome parameters of bone thickness and arch dimensions were then compared to check and compare the effectiveness of each group.
|