pulpal temperature evaluation after desensitization protocol by diode laser
Design
Parallel group, randomised controlled trial with 45 samples. Randomisation sequance will be carried out by table of random number(www.randomizer.org).
Settings and conduct
Laser Department of Tehran azad university of Dentistry
Participants/Inclusion and exclusion criteria
inferior or superior incisors or premolars with irreversible pulpitis with intact buccal surface.
Intervention groups
In group 1, diode Laser (810 nm) irradiation will be done with 200 microne tip size and power of 1 W for 10s, continious and non-contact mode( 1 mm from labial or buccal surface of teeth) and in group 2 irradiation will be done by 0.5 W, non-contact and continious mode( 2mm from tooth surface). Temperature changes will be recorded in these group. In control group, after access cavity preparation, temperature changes will be recorded.
Main outcome variables
temperature rising during laser emitting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170923036331N3
Registration date:2018-05-04, 1397/02/14
Registration timing:retrospective
Last update:2018-05-04, 1397/02/14
Update count:0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Zohreh Khalilak
Name of organization / entity
Islamic Azad University- Dental school- Endodontic department
Country
Iran (Islamic Republic of)
Phone
+98 22564571
Email address
z_khalilak@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2018-04-08, 1397/01/19
Expected recruitment end date
2018-04-20, 1397/01/31
Actual recruitment start date
2017-12-06, 1396/09/15
Actual recruitment end date
2017-12-21, 1396/09/30
Trial completion date
empty
Scientific title
A comparison of two dentin desensitizer protocols with diode laser(810 nm) in terms of intrapulpal temperature in patients with irreversible pulpitis
Public title
The effect of diode laser on pulpal temperature
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Vital teeth with irreversible pulpitis.
Buccal surface should be intact.
Teeth should be fully errupted and mature.
Patients' age is between 25 to 50
Exclusion criteria:
patients with systemic problems, any kind of drug usage including analgesics and sedative drugs and smokers
necrotic, troumatized, immature or calcified teeth
Age
From 25 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is individual stratified randomization.
Strata is including incisors and premolars. Randomization have done by random number generator (https://www.random.org) were used for randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic azad university of Tehran, Dental branch
Street address
Pasdaran, Neyestan 9
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-03-12, 1395/12/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1395.37
Health conditions studied
1
Description of health condition studied
intrapulpal temprature rise
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Intrapulpal temprature
Timepoint
2, 4, 6, 8, 10 seconds during Laser irradiation in group 1 and at 2, 4, 6, 8, 10, 15, 30, 45, 60 seconds during Laser irradiation in group 2 and temperature will be evaluate in control group up to 10 minutes.
Method of measurement
thermometer
Secondary outcomes
empty
Intervention groups
1
Description
interventional group 1: Laser irradiation will be done with following parameters: 1 W for 10 seconds, non-contact with continious mode by 200 micron tip at cervical portion of teeth (1mm from tooth surface). Thermocoupl will be placed through access cavity and will be fixed by cavite.
Category
Treatment - Other
2
Description
Intervention group 2: Laser irradiation will be done with following parameters: 0.5 W for 60 seconds, non-contact with continious mode and 60 j/cm2 energy density( 2mm from tooth surface). Thermocoupl will be placed through access cavity and will be fixed by cavite.
Category
Treatment - Other
3
Description
Control group: access cavity preparation and temperature evaluation without laser irradiation
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic azad university of Tehran, Dental branch
Full name of responsible person
Delaram Bineshmarvasti
Street address
No4, Neyestan 9, Pasdaran ave, Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4570
Email
dlrmbm@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch institution of Islamic azad university of Tehran، Dental branch
Full name of responsible person
Arash Azizi
Street address
No.4, Neyestan 9, Pasdaran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4570
Email
dlrmbm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch institution of Islamic azad university of Tehran، Dental branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic azad university of Tehran, Dental branch
Full name of responsible person
Delaram binesh marvasti
Position
Post graduate student of endodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran, 9th Neyestan
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2278 3793
Fax
Email
dlrmbm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic azad university of Tehran Dental branch
Full name of responsible person
Zohreh khalilak
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran, Neyestan 9
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4571
Fax
Email
z_khalilak@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran Islamic azad university of dentistry
Full name of responsible person
Delaram bineshmarvasti
Position
post-graduate student of endodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 4, Neyestan 10, Pasdaran ave.,Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4570
Fax
Email
dlrmbm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcome measure only
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
no condition
From where data/document is obtainable
Dr. Delaram Bineshmarvasti
09122347608
What processes are involved for a request to access data/document
phone contact/give their email address /it takes one week to send data to the email address