| CTRI Number |
CTRI/2024/07/070492 [Registered on: 11/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To check the accuracy of braces placement using two different techniques. |
|
Scientific Title of Study
|
A Comparative Evaluation of Accuracy of Bracket Placement Using Direct and Indirect bonding Technique. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Apda Darang |
| Designation |
Post Graduate student |
| Affiliation |
Atal Bihari Vajpayee Medical University,Lucknow,Uttar Pradeshl |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, third floor, room no.1
Indraprastha Dental College and Hospital, Sahibabad, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
09362978213 |
| Fax |
|
| Email |
apdadarang55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rahul Paul |
| Designation |
Principal,professor and HOD |
| Affiliation |
Indraprastha dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1, Inderprastha Dental College and Hospital, Shahibabad, Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9362978213 |
| Fax |
|
| Email |
drrahulpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Apda Darang |
| Designation |
Post Graduate Student |
| Affiliation |
indraprastha dental college and hospital |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1, Inderprastha Dental College and Hospital, Shahibabad, Ghaziabad Ghaziabad
Ghaziabad
UTTAR PRADESH
201010
India |
| Phone |
9362978213 |
| Fax |
|
| Email |
apdadarang55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Inderprastha Dental College and Hospital, Sahibabad, Ghaziabad, Uttar Pradesh, India, 201010 |
|
|
Primary Sponsor
|
| Name |
Dr Apda Darang |
| Address |
Department of orthodontics and dentofacial orthopaedics, third floor, room no 1, Inderpratsha Dental College and Hospital, Shahibabad, Ghaziabad, Uttar pradesh, India, 201010 |
| Type of Sponsor |
Other [Dr. Apda Darang] |
|
|
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 Apda Darang |
Indraprastha dental college and hospital |
Department of orthodontics and dentofacial orthopaedics, third floor, room no.1, Indraprastha dental college and hospital, Ghaziabad, Uttar Pradesh
Ghaziabad
UTTAR PRADESH |
09362978213
apdadarang55@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
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 |
direct bracket bonding |
bracket placement accuracy of borth direct and indirect |
| Comparator Agent |
direct bracket bonding technique
|
bracket bonding accuracy of indirect bonding |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals in age group between 12 to 25 years Permanent dentition  Patients requiring fixed orthodontic treatment  Normal & fully erupted teeth Good mouth opening
|
|
| ExclusionCriteria |
| Details |
Worn out / fractured dentition  Incisal edge / cusp tip with previous restoration  Dentition with unerupted / incompletely erupted teeth  Dentition with severe crowding/ abnormal position of teeth which can impede simultaneous bracket placement on all teeth. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the bracket placement accuracy in direct and indirect bracket placement |
T0- Baseline
T1- at time of bracket placemnet
T2- after 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/07/2024 |
| Date of Study Completion (India) |
10/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-04-2025 and end date provided 14-07-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Aim of the study: The aim of this study was to compare the direct and indirect bracket bonding techniques to identify the bonding technique which enables the most accurate bracket positioning
Obejctive of the study: To measure the variation in vertical positioning of brackets in direct and indirect bonding techniques. To measure the variation in horizontal positioning of brackets in direct and indirect bonding techniques. To measure the angular variation in bracket positioning in direct and indirect bonding techniques.
Null hypothesis: No difference in the accuracy between direct and indirect bracket placement |