This study with the aim of "Evaluation of Clinical effects of 940 nm Diode laser irradiation on post bleaching sensitivity reduction according to the common technique" is a prospective double blind clinical trial study. 30 persons with the tooth whitening requirement will take part in our study. Participants should be 18-35 years old, caries free, no periodontal and tooth sensitivity disease especially for anterior teeth, canines and premolars. Bleaching technique according to the therapeutic instructions will be performed on both mandibular and maxillary teeth, then the teeth of a randomized jaw will be irradiated by Diode laser with specified irradiation characteristics. Afterward, tooth sensitivity degree will be measured according to the VAS technique in 1, 24, 48 hrs and 7 days after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017010231732N1
Registration date:2017-02-15, 1395/11/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Loghman Rezaei-Soufi
Name of organization / entity
Department of Restorative Dentistry, Dental Research Center, Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0262
Email address
loghmansofi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology vice chancellor of Hamadan University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clinical effects of 940 nm Diode laser irradiation on post bleaching sensitivity reduction according to the common technique
Public title
Laser effect of bleaching teeth sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
-Inclusion criteria:
No caries and periodontal diseases in all anterior teeth, canines and premolars of upper and lower jaw; Lack of any permanent and temporary restorations on more than 1/4 labial surface all anterior teeth, canines and premolars of upper and lower jaw; Lack of any tooth sensitivity ( assessed by dental air-water spray); Persons with aged over 18 years and less than 30 years; cooperation ability for periodical follow-up; Lack of any analgesic drugs consumption at least 72 hrs before bleaching; Lack of any desensitizing toothpaste usage at least 6 weeks before bleaching
- Exclusion criteria:
Pregnancy and breast feeding; Patient with periodontal diseases or under treatment; History of tooth bleaching treatment; Tetracycline tooth discoloration; Smoking; Tooth sensitivity; History of tooth sensitivity treatment
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Street address
Hamedan University of Medical Scinces
City
Hamedan
Postal code
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
IR.UMSHA.REC.1395.413
Health conditions studied
1
Description of health condition studied
Tooth sensitivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
Tooth sensitivity
Timepoint
1, 24, 48 hrs and 7 days after intervention
Method of measurement
According to VAS technique
Secondary outcomes
empty
Intervention groups
1
Description
- Control group: For being patient blindness, the opposite teeth surfaces of intervention group will be irradiated only by laser guiding beam for 60s.
Category
Treatment - Other
2
Description
- Intervention group: The teeth of one of the randomized jaws, immediately after bleaching, Diode laser (Biolase, USA) with 940 nm wave length, 1w power, no sound, continuously and sweeping movement from 5 mm distance, none contact,
wiil be irradiated on study group teeth by a specialist person.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental research center of Hamedan University of Medical Sciences
Full name of responsible person
Dr. loghman rezaei sofi
Street address
School of Dentistry, Hamedan University of Medical Sciences, Shahid Fahmideh Street, Hamedan City, Hamedan, Iran.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rsearch and technology vice chancellor of Hamedan University of Medical Sciences
Full name of responsible person
Leila asgary
Street address
Rsearch and technology vice chancellor, Hamedan University of Medical Sciences, Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rsearch and technology vice chancellor of Hamedan 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
Dental research center of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Loghman rezaei soufi
Position
Associate Professor of Esthetic and Operative Dentistry
Other areas of specialty/work
Street address
Dental Research Center, Hamedan University of Medical Sciences, Hamedan, Iran.
City
Hamedan
Postal code
Phone
+81 38380262
Fax
Email
loghmansofi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental Research Center of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Loghman rezaei soufi
Position
Associate Professor of Esthetic and Operative Dentistry
Other areas of specialty/work
Street address
Dental research center, Hamedan University of Medical sciences, Shahid Fahmideh street, Hamedan city, Hamadan, Iran.
City
Hamedan
Postal code
Phone
+81 38380262
Fax
Email
loghmansofi@umsha.ac .ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental Research Center of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Loghman Rezaeisofi
Position
Associate Professor of Esthetic and Operative Dentistry
Other areas of specialty/work
Street address
Dental research center, Hamedan University of Medical sciences, Shahid Fahmideh street, Hamedan city, Hamadan, Iran.
City
Hamadan
Postal code
Phone
+81 38380262
Fax
Email
Loghmansofi@umsha.ac.ir
Web page address
http://drc.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)