The effect of 810nm diode laser on the onset and depth of anesthesia during root canal treatment of mandibular first molars with symptomatic irreversible pulpitis.
44 patient with symptomatic irreversible pulpitis were included. Randomly allocated in to laser and placebo group. in treatment group low level laser therapy is applied on periapical region of first mandibular molar area, all teeth anesthetized using 1.8 ml of 2% lidocaine delivered with inferior alveolar nerve block technique. root canal therapy is initiated after 15 minutes , the patients were asked about felt pain during this procedure using HP-VAS , the person who perform root canal therapy is unaware of aims of study and trial protocol. if the patient felt moderate to severe pain that cannot be tollerated, the procedure is halted and receive supplementary anesthesia.
Participants/Inclusion and exclusion criteria
Inclusion criteria
diagnosis of irreversible pulpitis
understanding HP-VAS
the existence of contralateral canine without histrory of previous restoration or trauma
the patient should be in access to obtain information about
written informed consent
minimum age of 18 and maximum age of 60 years
Exclusion criteria
history of systemic conditions
use of cardiac pace maker
signs of periapical lesion in the radiographic examination
history of use of antibiotics over the past week or analgesics over the last 24 hours
Intervention groups
Intervention group: Radiation of a diode laser with a power of 300 mW and a density of 15 J/cm2 In the buccal region of first mandibular molar for 20 seconds Control group: Placebo laser radiation (energy free) in the buccal region of first mandibular molar for 20 seconds
Main outcome variables
pulpal anesthesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181222042076N1
Registration date:2019-10-06, 1398/07/14
Registration timing:registered_while_recruiting
Last update:2019-10-06, 1398/07/14
Update count:0
Registration date
2019-10-06, 1398/07/14
Registrant information
Name
leila ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 1139
Email address
leilaghasemi681@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-03, 1397/11/14
Expected recruitment end date
2020-02-03, 1398/11/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 810nm diode laser on the onset and depth of anesthesia during root canal treatment of mandibular first molars with symptomatic irreversible pulpitis.
Public title
The effect of 810nm diode laser on mandibular first molar anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
diagnosis of irreversible pulpitis via thermal tests
understanding HP-VAS
the existence of contralateral canine without histrory of previous restoration or trauma
the patient should be in access to obtain information about
written informed consent
minimum age of 18 and maximum age of 60 years
Exclusion criteria:
history of systemic conditions, such as cardiovascular diseases, diabetes mellitus, cancer or psychiatric diseases
use of cardiac pace maker
signs of periapical lesion in the radiographic examination of the examined tooth
history of use of antibiotics over the past week or analgesics over the last 24 hours
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
six digit number created with random number generator (excel 2017)
the allocation process is concealed by placing treatment group paper in opaque sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
participants, principle investigators includes: the person that do laser application, the person that perform local anesthesia, the person that perform root canal therapy procedure and the person that collect the results.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan university of medical science
Street address
Hamadan university of medical science,Fahmieh S.t,Pazhouhesh Sq,Beasat Blv,
City
Hamadan
Province
Hamadan
Postal code
65417838741
Approval date
2019-01-22, 1397/11/02
Ethics committee reference number
IR.UMSHA.REC.1397.695
Health conditions studied
1
Description of health condition studied
lOCAL anesthesia
ICD-10 code
Y48.3
ICD-10 code description
lOCAL ANAESTHETICS
Primary outcomes
1
Description
pulpal anesthesia
Timepoint
During pulpectomy
Method of measurement
HP-VAS Pain assessment tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Radiation of a diode laser with a power of 300 mW and a density of 15 J/cm2 In the buccal region of first mandibular molar for 20 seconds
Category
Treatment - Devices
2
Description
Control group: Placebo laser radiation (energy free) in the buccal region of first mandibular molar for 20 seconds
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department, School of dentistry,Hamadan university of medical science
Full name of responsible person
Rooholah Behrouzi
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Email
roohbeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr.Saeed Bashirian
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
roohbeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Rooholah Behroozi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of endodontics, School of dentistry, Hamadan university of medical sciences, Shahid Fahmide st., Pazhuhesh sq.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
roohbeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rooholah Behroozi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of endodontics, School of dentistry, Hamadan university of medical sciences,Shahid Fahmide st., Pazhuhesh sq.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
roohbeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Rooholah Behroozi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of endodontics, School of dentistry, Hamadan university of medical sciences, Shahid Fahmide st.,Pazhuhesh sq.
City
Hamadan
Province
Hamadan
Postal code
65417838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
roohbeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
we will provide information regarding primary outcome measure, sex and age range of precipitants, response to treatment
When the data will become available and for how long
after publication of the final article
To whom data/document is available
researchers who works in university
Under which criteria data/document could be used
the data will provide for using in review studies or future clinical trials if cited as regular