Comparison the effect of visible and invisible laser irradiation on sensitivity and color of teeth after bleaching in patients with discolored teeth: A randomized clinical trial
Our main objectives are evaluation the effect of low power visible and invisible laser irradiation on the sensitivity and color of teeth after bleaching. This is a randomized, single blind and placebo-controlled study. Patients who agree to participate in the study will be chosen. Patients with six healthy sound maxillary anterior teeth will be included in the study and patients with tooth sensitivity before bleaching treatment and severe tooth discoloration will be excluded from the study. Patients will be divided into 3 groups randomly. Randomization will be performed by choosing sealed envelopes containing different treatment protocols. After isolation, the anterior maxillary teeth will be bleached with Hydrogen Peroxide 35% gel according to manufacturer’s instruction. After the end of bleaching procedure, in experimental groups, the low power diode laser; “Thor” (with 660 or 810 nm wavelength, power density 800 mW/cm2, energy density 12 J/cm2, output power 200 mW) will be used on the cervical third of each tooth in contact mode with surface area of 0.25 cm2 for 15 seconds. To consider the placebo effect in control group turned-off laser will be used in the same manner as experimental groups. For each patient two bleaching sessions with one week interval will be done. The pain intensity will be measured based on visual analogue scale immediately, 24 and 48 hours after the end of the bleaching procedure. The color change will be evaluated 30 days after the end of the bleaching procedure with optical and instrumental methods.
General information
Acronym
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IRCT registration information
IRCT registration number:IRCT201408131509N2
Registration date:2015-03-22, 1394/01/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-03-22, 1394/01/02
Registrant information
Name
Horieh Moosavi
Name of organization / entity
Dental School of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1869 1500
Email address
moosavih@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of visible and invisible laser irradiation on sensitivity and color of teeth after bleaching in patients with discolored teeth: A randomized clinical trial
Public title
Effect of laser irradiation on sensitivity and color of teeth after bleaching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with minimum age of 18 years who agree to participate in the study; Patients with at least six sound maxillary anterior teeth
Exclusion criteria:
Patients who have not received bleaching treatment previously; Pregnant and lactating women; patients having cardiac pacemaker; patients who receive drugs affecting the perception of pain (analgesic, anti-inflammatory, etc.); patients with heavy occlusion and bruxism; patients with tooth sensitivity before bleaching treatment; patients with severe tooth discoloration (tetracycline, fluorosis, etc.); Patients with gingival and periodontal problems and history of periodontal surgery in the past 6 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The study is single blind and the patient will not aware of irradiation the visible or invisible lasers and will mark her/his sensitivity in the questionnaire by visual analogue scale.
Randomization will be performed by choosing sealed envelopes containing different treatment protocols.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Ghoraishy Building, University St.
City
Mashhad
Postal code
Approval date
2014-05-24, 1393/03/03
Ethics committee reference number
921922
Health conditions studied
1
Description of health condition studied
Sensitivity after tooth bleaching
ICD-10 code
Y56.7
ICD-10 code description
Dental drugs, topically applied
Primary outcomes
1
Description
Sensitivity after tooth bleaching
Timepoint
Immediately,24 and 48 hours after end of bleaching
Method of measurement
Visual analogue scale
Secondary outcomes
1
Description
Tooth color
Timepoint
30 days after end of bleaching
Method of measurement
Optical and instrumental methods
Intervention groups
1
Description
Using visible laser with 660 nm wavelength
Category
Treatment - Other
2
Description
Using invisible laser with 810 nm wavelength
Category
Treatment - Other
3
Description
Using turned-off laser
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry of Mashhad
Full name of responsible person
Dr.Hoorieh Moosavi
Street address
School of Dentistry, Opposite of Mellat Park, Vakil Abad Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Mohsen Tafaghodi
Street address
Ghoraishy Building, University St.
City
Mashhad
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, Mashhad 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
School of Dentistry
Full name of responsible person
Dr.Hoorieh Moosavi
Position
Associate Professor
Other areas of specialty/work
Street address
School of Dentistry, Opposite of Mellat Park, Vakil Abad Blvd
City
Mashhad
Postal code
91735
Phone
+98 513882950115
Fax
+98 38829500
Email
moosavih@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad School of Dentistry
Full name of responsible person
Dr.Hoorieh Moosavi
Position
Associate Professor
Other areas of specialty/work
Street address
School of Dentistry, Opposite of Mellat Park, Vakil Abad Blvd
City
Mashhad
Postal code
91735
Phone
+98 513882950115
Fax
+98 38829500
Email
moosavih@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr.Hoorieh Moosavi
Position
Associate Professor
Other areas of specialty/work
Street address
School of Dentistry, Opposite of Mellat Park, Vakil Abad Blvd
City
Mashhad
Postal code
Phone
+98 513882950115
Fax
Email
moosavih@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)