| CTRI Number |
CTRI/2022/01/039148 [Registered on: 05/01/2022] Trial Registered Prospectively |
| Last Modified On: |
03/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial two see the movement of teeth using two different brackets |
|
Scientific Title of Study
|
Comparative evaluation of alignment efficiency and arch development in two passive self ligating bracket systems |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Anna Thomas |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162 Poonamallee high road
Chennai-600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
dranjali85400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Harish Babu |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162 Poonamallee high road
Chennai-600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
harish.ortho@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harish Babu |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental College and Hospitals
162 Poonamallee high road
Chennai-600077
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
harish.ortho@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals
162 Poonamallee high road
Cheenai-600077 |
|
|
Primary Sponsor
|
| Name |
Anjali Anna Thomas |
| Address |
Puthenkulangara House
Avalukunnu P.O
Kerala-688006 |
| 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 |
| Anjali Anna Thomas |
Saveetha Dental College and Hospitals |
Department of Orthodontics
162 Poonamallee high road
Chennai-600077
Thiruvallur
TAMIL NADU |
9447085400
dranjali85400@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K009||Disorder of tooth development, unspecified, (2) ICD-10 Condition: K009||Disorder of tooth development, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Passive self ligating AO bracket |
Intervention group bonded with passive self ligating American Orthodontic brackets from premolar to premolar in both upper and lower arches and 1st and 2nd molars bonded with buccal tubes. |
| Comparator Agent |
Passive self ligating Damon bracket |
Comparison group bonded with passive self ligating Damon bracket from premolar to premolar and 1st and 2nd molars bonded with buccal tubes. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the age group of 15-30 years with mild to moderate crowding of the anteriors requiring fixed orthodontic treatment without extraction protocol. |
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Patients with spacing in the dentition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of decrowding |
8th week , 12 week, end of leveling aligning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
rate of decrowding, maxillary arch width and incisor
inclination change. |
pre treatment and towards the end of the treatment |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
25/01/2022 |
| 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="8"
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)?
Response - NO
|
|
Brief Summary
|
The purpose of this Randomized controlled trial is to compare the alignment efficiency ,maxillary arch width and incisor inclination change of AO and Damon Q passive self ligating bracket systems using Tanzo and Damon CuNiTi wires respectively.10 patients in the intervention group ,strapped up with AO self ligation bracket system and 10 patients in the comparison group strapped up with Damon self ligating bracket system.wire sequencing is 0.013,14*25,18*25 CuNiTi and 19825 SS.Intraoral scans are taken after 8th week of wire placement and wires changed at 12 week.Rate of decrowding is measured using Little’s irregularity index.Arch expansion recorded using mesurements in the 3shape orthoanalyser software. |