IRCT | Effect of co2 laser irradiation on the surface of the polycrystalline ceramic bracket and the rate of Canine movement with sliding mechanic

Protocol summary

Study aim: Effect of co2 laser irradiation on the surface of the polycrystalline ceramic bracket and the rate of canine movement with sliding mechanic
Design: Clinical trial with control group, parallel group, double blind, randomized
Settings and conduct: Babol university of medical science, college of dentistry, Department of Orthodontics All members of this study except analyzers are blinded.
Participants/Inclusion and exclusion criteria: Patient with crowding and protrusion without any totally blocked out tooth.
Intervention groups: In the control group we bond normal brackets. In the case group we bond irradiated.
Main outcome variables: Change in the rate of tooth movement

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180314039093N1

Registration date: 2018-04-17, 1397/01/28

Registration timing: prospective

Last update: 2018-04-17, 1397/01/28

Update count: 0
Registration date: 2018-04-17, 1397/01/28

Registrant information: Name

Mostafa Ebrahimi

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 11 3229 7951

Email address

m.ebrahimi@mubabol.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-05-05, 1397/02/15
Expected recruitment end date: 2018-06-05, 1397/03/15
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Effect of co2 laser irradiation on the surface of the polycrystalline ceramic bracket and the rate of Canine movement with sliding mechanic

Public title: Effect of co2 laser irradiation on the surface of the polycrystalline ceramic bracket and the rate of Canine movement with sliding mechanic
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Patient with protrusion and crowding

Exclusion criteria:

Totally blocked out Canine or Premolar
Age: No age limit
Gender: Both

Phase

N/A

Groups that have been masked

Participant
Care provider
Investigator
Outcome assessor

Sample size

Target sample size: 7

More than 1 sample in each individual

Number of samples in each individual: 4

In each jaw there is one case and one control.

Randomization (investigator's opinion)

Randomized

Randomization description

Method: simple Unit: individual Tool: randomized number table

Blinding (investigator's opinion)

Double blinded

Blinding description

Brackets are divided into two groups; irradiated and not irradiated and all members except the third person are unaware.

Placebo

Not used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of babol university of medical sciences

Street address

babol university of medical science, Entefazeh Sqr

City

Babol

Province

Mazandaran

Postal code

4717643633
Approval date: 2018-02-26, 1396/12/07
Ethics committee reference number: MUBABOL.HRI.REC.1396.216

Health conditions studied

1

Description of health condition studied: Orthodontics with extraction
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Rate of space closure
Timepoint: Measurement of available space in 4, 8 and 12 weeks after force application
Method of measurement: Caliper

Secondary outcomes

empty

Intervention groups

1

Description: Intervention group: Use of ceramic brackets that irradiated with co2 laser, for retraction
Category: Treatment - Devices

Recruitment centers

1

Recruitment center: Name of recruitment center

college of dentistry, Babol university of medical science

Full name of responsible person

Mostafa Ebrahimi

Street address

Babol university of medical science, Entefazeh Sqr

City

Babol

Province

Mazandaran

Postal code

4717643633

Phone

+98 11 3219 0617

Fax

+98 11 3229 1093

Email

m.ebrahimi@mubabol.ac.ir

1

Sponsor: Name of organization / entity

Babol University of Medical Sciences

Full name of responsible person

Reza Ghadimi

Street address

Babol university of medical science, Entefazeh Sqr

City

Babol

Province

Mazandaran

Postal code

4717643633

Phone

+98 11 3219 0617

Email

m.ebrahimi@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Babol University of Medical Sciences
Proportion provided by this source: 100
Public or private sector: Public
Domestic or foreign origin: Domestic
Category of foreign source of funding: empty
Country of origin
Type of organization providing the funding: Academic

Person responsible for general inquiries

Contact: Name of organization / entity

Babol University of Medical Sciences

Full name of responsible person

Mostafa Ebrahimi

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dentistry

Street address

Felestin Ave, Entefaze Square

City

Babol

Province

Mazandaran

Postal code

4717643633

Phone

+98 11 3229 7951

Fax

Email

ebrahimi.mostafa1991@gmail.com

Person responsible for scientific inquiries

Contact: Name of organization / entity

Babol University of Medical Sciences

Full name of responsible person

Mostafa Ebrahimi

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dentistry

Street address

Felestin Ave, Entefaze Square

City

Babol

Province

Mazandaran

Postal code

4717643633

Phone

+98 11 3229 7951

Fax

Email

ebrahimi.mostafa1991@gmail.com

Person responsible for updating data

Contact: Name of organization / entity

Babol University of Medical Sciences

Full name of responsible person

Mostafa Ebrahimi

Position

Resident

Latest degree

Medical doctor

Other areas of specialty/work

Dentistry

Street address

Felestin Ave, Entefaze Square

City

Babol

Province

Mazandaran

Postal code

4717643633

Phone

+98 11 3229 7951

Fax

Email

ebrahimi.mostafa1991@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD): Yes - There is a plan to make this available
Study Protocol: Yes - There is a plan to make this available
Statistical Analysis Plan: Not applicable
Informed Consent Form: Yes - There is a plan to make this available
Clinical Study Report: Yes - There is a plan to make this available
Analytic Code: Yes - There is a plan to make this available
Data Dictionary: Not applicable
Title and more details about the data/document: All information
When the data will become available and for how long: 6 months after publication
To whom data/document is available: employees in academic institutions
Under which criteria data/document could be used: With reference to the original article, the use of the results provided is permissible.
From where data/document is obtainable: Research center of dentistry college, medical university of Babol
What processes are involved for a request to access data/document: Request to research center of dentistry college, medical university of Babol
Comments

Effect of co2 laser irradiation on the surface of the polycrystalline ceramic bracket and the rate of Canine movement with sliding mechanic