CTRI

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CTRI Number

CTRI/2018/04/013156 [Registered on: 10/04/2018] Trial Registered Retrospectively

Last Modified On:

27/03/2018

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Medical Device
Dentistry

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

To check the effect of laser treatment on the rate of orthodontic tooth movement using two types of orthodontic brackets-specialized and normal brackets.

Scientific Title of Study

"To evaluate the effect of low-intensity laser therapy on the rate of orthodontic tooth movement using self-ligation and conventional brackets"-A clinical prospective study.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Puneet Batra
Designation	Professor and Head of Department
Affiliation	Institute Of Dental Studies And Technologies(IDST)
Address	Institute of Dental Studies and Technologies,Department of Orthodontics and Dentofacial Orthopedics,1st Floor,Room No.4,Kadrabad,Modinagar. Ghaziabad UTTAR PRADESH 201201 India
Phone	9810335961
Fax
Email	drpuneetbatra@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Puneet Batra
Designation	Professor and Head of Department
Affiliation	Institute Of Dental Studies And Technologies(IDST)
Address	Institute of Dental Studies and Technologies,1st Floor,Room No.4,Department of Orthodontics and Dentofacial Orthopedics,Kadrabad,Modinagar. Ghaziabad UTTAR PRADESH 201201 India
Phone	9810335961
Fax
Email	drpuneetbatra@gmail.com

Details of Contact Person
Public Query

Name	Dr H Lalnunpuii
Designation	Post Graduate student
Affiliation	Institute Of Dental Studies And Technologies(IDST)
Address	Institute of Dental Studies and Technologies,1st Floor,Room No.4,Department of Orthodontics and Dentofacial Orthopedics,Kadrabad,Modinagar N.H.-58,Delhi-Meerut Road,Kadrabad,Modinagar-201201,Distt.Ghaziabad (U.P.),Ph.:-01232-231516 Ghaziabad UTTAR PRADESH 201201 India
Phone	8875372246
Fax
Email	mami.hmar@ymail.com

Source of Monetary or Material Support

Institute of Dental Studies and Technologies,Kadrabad,Modinagar.

Primary Sponsor

Name	Dr H Lalnunpuii
Address	Institute Of Dental Studies And Technologies,Delhi-Meerut Road,NH-58,Kadrabad, Modinagar,Uttar Pradesh-201201
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr H Lalnunpuii	Institute Of Dental Studies And Technologies Kadrabad Modinagar	Department Of Orthodontics And Dentofacial Orthopedics Room Number 4 First Floor Kadrabad Modinagar 201201 Ghaziabad UTTAR PRADESH	8875372246 mami.hmar@ymail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institute Of Dental Studies And Technologies	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Healthy,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Conventional Brackets	These are the brackets which uses elastic modules or ligature wire to engage wire in to the bracket slot.
Intervention	Low level laser therapy	Low level laser therapy uses a wavelength of 660nm and energy output of 2.2J for 10 seconds on each appointment. The laser will be applied on the 1st,3rd,7th,14th day in first month and on every 21st day on the following month of retraction until space closure is achieved.
Comparator Agent	Self-ligating brackets (Smartclip SL3)	These are the brackets which has clips to engage the arch wire throughout the treatment.

Inclusion Criteria

Age From	17.00 Year(s)
Age To	30.00 Year(s)
Gender	Both
Details	1)Class I and Class II malocclusion 2)Bimaxillary protrusion 3)Healthy patient without any systemic diseases. 4)Good oral hygiene. 5)Patient requiring first premolar extractions. 6)No previous orthodontic treatment.

ExclusionCriteria

Details

1)History of long term medication
2)Radiographic evidence of periodontal bone loss.
3)Impacted canines and canines with dilacerated roots.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Rate of tooth movement in an enmasse retraction	1year

Secondary Outcome

Outcome	TimePoints
Nil	Not applicable

Target Sample Size

Total Sample Size="30"
Sample Size from India="10"
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 4

Date of First Enrollment (India)

05/06/2017

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details

Not yet published

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Brief Summary

Aim of the study:-

1. To compare the rate of orthodontic tooth movement between patients treated with self-ligation (Smartclip SL3) and conventional brackets (MBT 0.022â€) with low level laser therapy in extraction cases.

2. To compare the rate of orthodontic tooth movement between patients treated with conventional brackets (MBT 0.022â€) with and without low level laser therapy in extraction cases.