The aim of this study is determine the effect of CO2 laser radiation on prevention of enamel white spot lesions around orthodontic brackets. For this purpose 548 upper anterior teeth will randomly be selected from orthodontic patients from 12-30 years old and divided into two groups (Test and Control). At baseline test group will be irradiated by CO2 laser and control group be irradiated by placebo laser. Immediately after treatment and 6 months later intra-oral photographs of teeth will be taken. Estimating incidence of white spot lesions, number of teeth will be counted and the span of the lesions will be computed by percent. Also, the extent of the lesions will be determined using enamel decalcification index. The data will statistically be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052927362N2
Registration date:2017-07-02, 1396/04/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Majid Mahmoodzade
Name of organization / entity
Dental college
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0262
Email address
mahmoodzadeh@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental (Hamadan Dentistry College)
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2017-11-21, 1396/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of co2 laser irradiation on prevention of white spot lesions around orthodontic brackets,randomized clinical trial
Public title
The effect of co2 laser on prevention of white spot lesions
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
12-30 years old patients required orthodontic treatments; accept all of procedures and protocols of the study from the subjects; willingness to signing informed consent for disclosure of personal health information and using the data for research by anonymous.
Exclusion criteria:
Suffering systemic diseases or having medical history (i.e. Diabetes, HIV, or Heart disease needed to preventive antibiotic) so it could affect on oral health.
Age
From 12 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
548
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pazhoohesh Crossroads
City
Hamadan
Postal code
654178-38741
Approval date
2017-05-13, 1396/02/23
Ethics committee reference number
IR.UMSHA.REC.1396.146
Health conditions studied
1
Description of health condition studied
Enamel white spot lesion
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel White spot lesions [initial caries]
Primary outcomes
1
Description
The incidence of white spot lesions
Timepoint
Immediately after treatment and six months after treatment
Method of measurement
Counting teeth with white spot lesions
Secondary outcomes
1
Description
Extent of white spot lesions
Timepoint
Immediately after treatment and six months after treatment
Method of measurement
Using Enamel Decalcification Index
2
Description
Intensity of demineralization
Timepoint
Immediately after treatment and six months after treatment
Method of measurement
Using Scoring system
Intervention groups
1
Description
In test group, after bonding brackets, enamel surface will be exposed by by CO2 laser (DEKA Laser Technologies,Florence,Italy) with a power of 0.4 mW, wave length of 10.6 micrometer, 5 hertz, diameter 0.2 mm and pulse time 0.9 seconds. To do this, the teeth will be at distance of 5 mm from the tip of the device and person constantly will irradiate entire surface by reciprocating standard movements in 10 seconds. Laser irradiation will be performed by direct laser handpieces.
Category
Prevention
2
Description
In control group, after bonding the brackets, placebo laser will be irradiated.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental College
Full name of responsible person
Somayeh karami
Street address
City
Hamadan
2
Recruitment center
Name of recruitment center
Special Clinic of Dental college
Full name of responsible person
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and technology, Hamadan University of Medical Sciences
Full name of responsible person
Saeed Bashirian
Street address
Opposite the Mardom Park, Shahid Fahmide Boulevard, Pazhoohesh Crossroads
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and technology, Hamadan 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 College, Hamadan University of Medical Sciences
Full name of responsible person
Somayeh Karami
Position
Professional Doctorate in Dentistry
Other areas of specialty/work
Street address
Pazhoohesh Crossroads, Shahid Fahmideh Blvd, opposite the Mardom park
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
dr.karami5@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental college, Hamadan University of Medical Sciences
Full name of responsible person
Somayeh karami
Position
Professional Doctorate in dentistry
Other areas of specialty/work
Street address
Dental College, Opposite the Mardom Park, Shahid Fahmide Boulevard, Pazhooheh Crossroads
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
dr.karami5@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental College, Hamadan University of Medical Sciences
Full name of responsible person
Somayeh karami
Position
Professional Doctorate in dentistry
Other areas of specialty/work
Street address
Dental College, Opposite the Mardom Park, Shahid Fahmide Boulevard, Pazhooheh Crossroads
City
Hamadan
Postal code
Phone
+98 81 3838 1059
Fax
Email
dr.karami5@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)