Protocol summary

Summary
Research is randomized, not blinded, without using placebo. Inclusion criteria are patients without extraction and with moderate crowding (5-9 mm), rotated teeth less than 30 degrees. Group 1: who are treating with a diode laser to alleviate relaps. The laser emit a wavelength of 810 nm and operate in continuous wave mode with maximum power of 200 mW from the mesial maxillary canine of one side to the opposite side. The laser probe will be position in contact with gingival tissue in the coronal third of the root, and the irradiation will perform on 4 points around the tooth, including mesiobuccal, distobuccal, mesiolingual, and distolingual areas. The laser irradiates for 50 seconds per point, and thus each tooth receive 200 seconds of laser irradiation. Laser will irradiate 2 times before removing arch wire (7days and immediately before removing arch wire). Immediately after bracket debonding, Dental impression will be taken. After 4 months of using fulltime retainer, impression will be taken. The patients are asked to use retainer about 8 hour per day for one month. The fourth impression will be taken after 6 months after removing arch wire. The second group will not be undergoing any laser radiation. Crowding will measure.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017053034061N1
Registration date: 2017-06-07, 1396/03/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Batoolalsadat Mousavi fard
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 3213 2944
Email address
b.mousavifard@gmail.com
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2017-04-03, 1396/01/14
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Short term effect of low-level laser therapy on tooth stability after orthodontic treatment
Public title
Laser effect on short term stability after orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1) cl 1 malocclusion 2) without extraction and moderate crowding (5-9mm) 3) rotated teeth less than 30 4) no systemic disease 5) good oral hygiene 6) not consuming medicine that interrupted bone metabolism Exclusion criteria: 1) diseases that laser irradiation is contraindicated 2) Gingival and periodontal inflammation
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple random sampling

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kerman university of medical sciences
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, Kerman
City
kerman
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.kmu.REc.1395.932

Health conditions studied

1

Description of health condition studied
Crowding
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Crowding
Timepoint
Immediate,4,5,6 months after treatment
Method of measurement
Milimeter by software

Secondary outcomes

1

Description
Crowding
Timepoint
Immediately,4,5,6 months after treatment
Method of measurement
Milimeter by software

Intervention groups

1

Description
Intervention group: The laser emitted a wavelength of 810 nm and operated in continuous wave mode with maximum power of 200 mw. The laser irradiate for 50 seconds per point, and thus each tooth receive 200 seconds of laser irradiation. Control group: no intrvention
Category
Treatment - Other

2

Description
Control group: without using placebo
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthodontic Department of Dental Faculty
Full name of responsible person
Street address
City
kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor research, Kerman university of medical sciences
Full name of responsible person
Abbas Pardakhti
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh Highway, kerman, Ira
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor research, Kerman university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Dentistry school
Full name of responsible person
Samaneh Sadeghi
Position
Assistant Professor
Other areas of specialty/work
Street address
Dentistry school, Shafa street, Kerman, Iran
City
kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
samaneh.sa82@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry school
Full name of responsible person
Batoolalsadat Mousavifard
Position
Doctor of Dentistry
Other areas of specialty/work
Street address
Dentistry school, Shafa street, Kerman, Iran
City
kerman
Postal code
Phone
+98 34 3211 9021
Fax
Email
b.mousavifard@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry school
Full name of responsible person
Batoolalsadat Mousavi fard
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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