CO2 laser has been shown by many in-vitro studies to have beneficial effects on enamel surface to increase its resistance to surface demineralization. The aim of this study is to evaluate the effect of CO2 laser on demineralization resistance of enamel surface in an in-vivo caries induction model. Since the people are accustomed to use fluoridated tooth paste for their oral hygiene care which has positive preventive effect on enamel surface, in this study the beneficial effect of CO2 laser will be examined in an environment that standard oral hygiene care is in progress.
In this split-mouth designed study, a minimum of 20 subjects will be enrolled. The subjects are ones who are scheduled for extraction of at least two premolars as part of their orthodontic treatment. The teeth must not have any filling or enamel defects. In each subject experimental tooth will be lased and the control tooth will receive just the guiding light. Both teeth will be subjected to caries induction during next 30 days while the patient will do the routine oral hygiene care. The teeth will be extracted and examine for surface micro-hardness and mineralization analysis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202209085N1
Registration date:2012-11-08, 1391/08/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-11-08, 1391/08/18
Registrant information
Name
Amirfarhang Miresmaeili
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 9064
Email address
miresmaeili@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences
Expected recruitment start date
2012-10-06, 1391/07/15
Expected recruitment end date
2013-10-06, 1392/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of CO2 laser on demineralization resistance of enamel surface around orthodontic brackets( an in vivo study)
Public title
Effect of laser on prevention of caries on teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Sound premolar teeth need to be extracted for orthodontic purposes on both sides
Exclusion criteria: Any restorations, enamel surface defects on each of the teeth under study or early loss of these teeth before completion of trial
Age
From 12 years old to 35 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The candidates will receive a number according to random number table. Candidates with odds number will receive laser illumination on left premolar and the even numbers will receive it on right premolar. Since illumination on both teeth uses the guided light and laser is not visible by itself, the candidate will not be noticed which teeth had received the laser and so have no preferences on oral hygiene care according to the type of illumination.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh street
City
Hamadan
Postal code
Approval date
2012-07-07, 1391/04/17
Ethics committee reference number
D/P/16/35/9/1259
Health conditions studied
1
Description of health condition studied
Other specified diseases of hard tissues of teeth
ICD-10 code
K03.8
ICD-10 code description
Irradiated enamel
Primary outcomes
1
Description
Surface micro-hardness of enamel
Timepoint
One month after laser/ Placebo application
Method of measurement
Micro-hardness test
Secondary outcomes
1
Description
Adhesive remnant index
Timepoint
after removal of brackets
Method of measurement
Total adhesive/ Half adhesive/ No adhesive remained
Intervention groups
1
Description
Teeth illumination with guided light (No Laser) as control
Category
Placebo
2
Description
In this study a Co2 Laser device (DEKA, Italy) with wave length of 10.6um, repetition rate of 50 Hz, beam diameter of 0.2 mm and power of 0.7w will be used. Outer surface of one premolar tooth in each patient will be swept from incisal tip to gingival margin horizontally.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Street address
Orthodontic Department
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
Dr. Heidar Tavilani,
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh street
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
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Faculty of Dentistry,Orthodontic Department
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Orthodontic Department, Faculty of Dentistry
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.com,miresmaeili@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Amirfarhang Miresmaeili
Position
Associate Professor
Other areas of specialty/work
Street address
Orthodontic Department, Faculty of Dentistry
City
Hamadan
Postal code
65178-38677
Phone
+98 81 1823 9064
Fax
+98 81 1823 4014
Email
amirfarhang@yahoo.commiresmaeili@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)