To determine the Effect of Two Types of High Power Diode Lasers 810nm and 980nm in the Treatment of Dentin Hypersensitivity
Design
Clinical trial with control group, parallel group trial with double blinded form. Randomisation was used with random number table.
Settings and conduct
This study will be done on patients with dentin hypersensitivity referring department of periodontics of Isfahan University. Two types of high power Diode lasers 810 and 980 nm are evaluated. Patient and statistician are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients referring to Dental Faculty of Isfahan University of Medical Sciences who have cervical dentin hypersensitivity in at least three teeth in three separate half-jaws. Teeth that are sensitive to cold stimulant testing. Exclusion criteria: caries; restored teeth; crown fracture; dental cracks; smokers; active periodontal disease; pregnancy; patients who have taken analgesics for 72 hours before the laser treatment; patients who have received anti-sensitivities toothpaste over the past 6 weeks.
Intervention groups
Radiation with 810 nm diode laser
Radiation with 980 nm diode laser
Main outcome variables
Initial improvement of dentin hypersensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120901010703N3
Registration date:2020-11-02, 1399/08/12
Registration timing:retrospective
Last update:2020-11-02, 1399/08/12
Update count:0
Registration date
2020-11-02, 1399/08/12
Registrant information
Name
Narges Naghsh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 5564
Email address
n_naghsh@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2020-04-24, 1399/02/05
Actual recruitment start date
2019-05-15, 1398/02/25
Actual recruitment end date
2020-01-20, 1398/10/30
Trial completion date
2020-01-20, 1398/10/30
Scientific title
Evaluation the Effect of Two Types of High Power Diode Lasers 810nm and 980nm in the Treatment of Dentin Hypersensitivity
Public title
Effect of Two Types of High Power Lasers in the Treatment of Dentin Hypersensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referring to dental faculty of Isfahan University of Medical Sciences who have cervical dentin hypersensitivity in at least three teeth in three separate half-jaws.
Teeth that are sensitive to cold stimulant testing.
Exclusion criteria:
Caries
Restored teeth
Crown fracture
Dental cracks
Smokers
Active periodontal disease
Pregnancy
Patients who have taken analgesics for 72 hours before the laser treatment
Patients who have received anti-sensitivities toothpaste over the past 6 weeks
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants selection in the study will perform by simple randomization method, individually and with random number table tools. In this way, a number will be written in front of the name of each person from the list of clients, then a table will be designed based on the sample size of the study, and we'll blindly touch a number of table numbers. The selected numbers will be included in the study if they are eligible after the examination. The intervention will be performed in a parallel design, and the choice of individuals for Intervention or Control will be randomly performed with coin instruments.In such a way that for both people whose names are accidentally put in the list, the first person uses ِDiode laser 810 and the second uses Diode laser 980, and vice versa if it is tails
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient and statistician are not informed of type of laser used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarhrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-01-05, 1394/10/15
Ethics committee reference number
کد تحقیقاتي: 394844
Health conditions studied
1
Description of health condition studied
Dentin hypersensitivity
ICD-10 code
G89.9
ICD-10 code description
Other chronic pain
Primary outcomes
1
Description
Amount of patient's pain
Timepoint
Before treatment, 15 minutes after first session, 15 minutes after second session, 1 week after end of treatment, 1 month after end of treatment, 2 months after end of treatment
Method of measurement
Using cold spray
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group treated by 810 nm laser, irradiation parameters are: power of 1 watt in a non-contact continues mode from a distance of 1 mm with the angle of 45 ° for 30 seconds with a sweeping motion. Treatments were carried out in two sessions, a weekly interval. The pain evaluated by using VAS (Visual Analyzing Scale) index by applying dry ice spray at all times.
Category
Treatment - Devices
2
Description
Intervention group: group treated by 980 nm laser, irradiation parameters are: power of 1 watt in a non-contact continues mode from a distance of 1 mm with the angle of 45 ° for 30 seconds with a sweeping motion. Treatments were carried out in two sessions, a weekly interval. The pain evaluated by using VAS (Visual Analyzing Scale) index by applying dry ice spray at all times.
Category
Treatment - Devices
3
Description
Control group: Without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of Medical Sciences
Full name of responsible person
Mahdieh Bijari
Street address
Isfahan University of Medical Sciences, Hezarjrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
mahdie.bijari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5512
Email
research@dnt.mui.ac.ir
Grant name
Shaghayegh Haghjoo Javanmard
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5564
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
narges naghsh
Position
assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan University of Medical Sciences, Hezarjrib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
0098317925564
Email
n_naghsh@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available