In randomized clinical trial study 44 patient with symptomatic irreversible pulpitis in mandibular teeth are selected.
in one(22 patient) group low level laser is exposed and another group are control. Pain intensity is measured before start of protocol with visual analog scale.electric pulp test is measured after and before of laser irradiation to buccal aspect of teeth.
Dose of laser is 15 j/cm2 with diode laser.laser irradiates before injection.electric pulp test is done immediately after irradiation of laser for measurement of nerve signal transmission. Inferior alveoular nerve block injection is done.index for success of injection is lip numbness. After that access cavity preparation is started and the pain measured during dentin cutting and exposure of pulp with visual analog scale.
General information
Acronym
tehran endodontic study
IRCT registration information
IRCT registration number:IRCT2016112631102N1
Registration date:2017-01-22, 1395/11/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Abbas Khosravi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8835 1173
Email address
sh-ghabraei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-01-29, 1395/11/10
Expected recruitment end date
2017-02-28, 1395/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser on the depth of anesthesia during treatment of lower mandibular molar r with irreversible pulpitis teeth
Public title
The effect of low level laser on the depth of anesthesia during treatment of lower mandibular molar with irreversible pulpitis teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: irreversible pulpitis in lower molar teeth, understanding of testimonial, accessibility to patient, age at least 18 years old. Exclusion criteria: history of systemic diseases, heart disease, diabetes, cancer, psychological problem, use of antibiotic and analgesic, malocclusion, lesion in mouth.
Age
From 18 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz blvd.
City
Tehran
Postal code
Approval date
2016-11-15, 1395/08/25
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1037
Health conditions studied
1
Description of health condition studied
Irreversible Pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
Before laser irradiation and during dentin and pulp exposure
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: usage of low level laser on the buccal of teeth and use the laser in the on mode.
Category
Treatment - Other
2
Description
Contorol group: keeping the low level laser on the buccal of teeth but not turn on the laser and use laser in the off mode.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endodontic department, Dentistry faculty, Tehran University of Medical Sciences
Full name of responsible person
Abbas Khosravi
Street address
Dentistry faculty, Tehran University of Medical Sciences, North Kargar street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Khosravi
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Abbas Khosravi
Position
Resident of endodontic
Other areas of specialty/work
Street address
Dentistry faculty, Tehran University of Medical Sciences, North Kargar street
City
Tehran
Postal code
Phone
+98 24 3344 6220
Fax
Email
abbaskhosravi45@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sholeh Ghabrayi
Position
Endodontist
Other areas of specialty/work
Street address
Dentistry faculty, Tehran University of Medical Sciences, North Kargar street
City
Tehran
Postal code
Phone
+98 21 8835 1173
Fax
Email
sholehghabraei@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Abbas Khosravi
Position
Resident of dentistry
Other areas of specialty/work
Street address
Dentistry faculty, Tehran University of Medical Sciences, North Kargar street
City
Tehran
Postal code
Phone
+98 24 3344 6220
Fax
Email
abbaskhosravi45@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)