The evaluation of location of low level laser irradiation on reducing the pain after endodontic treatment in patients with symptomatic irreversible pulpitis
The purpose of this study is the evaluation of effects of location of low level laser irradiation on reducing the pain after endodontic treatment in patients with symptomatic irreversible pulpitis.
This study will be done on first and second mandibular molar of 150 patients between 18 - 60 years old with tooth decay and diagnosis of symptomatic irreversible pulpitis. patients will be asked to record their initial pain on VAS. then will be divided into to groups : experimental(50 person) and placebo(25 person)
treatment group will be divided into 2 subgroups of "buccal irradiation" and "buccal and lingual irradiation"
Distribution of gender and average age and the presence of spontaneous pain in the subgroups will be even.
group 1 : laser placebo : sham irradiation
group 2 : laser group : *once laser irradiation (diode 808nm)
*twice laser irradiation (diode 808nm)
endodontic treatment of all patients will be done by endodontic specialist, in one meeting, with one technique and in the interval between 75 to 90 minutes.
after completion of endodontic treatment, in first subgroup, low level laser irradiates on buccal mucosa covering the mesial and distal roots for 80 seconds and in second subgroup the same procedure will be done on both buccal and lingual. patients will be asked to fill the VAS questionnaire at 4,8,24 and 48 hours after treatment. data will be compared and the final report will be prepared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017021432576N1
Registration date:2017-07-01, 1396/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-01, 1396/04/10
Registrant information
Name
Elham Moghadas
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 910 679 1069
Email address
e.moghadas@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal and School of Dentistry, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-08-23, 1396/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of location of low level laser irradiation on reducing the pain after endodontic treatment in patients with symptomatic irreversible pulpitis
Public title
The evaluation of effects of location of low level laser irradiation on reducing the pain after endodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Systemic healthy patients; Between 18 - 60 yrs; Have first or second mandibular molar with irreversible pulpitis; No periapical lesion in the radiography; Mobility less than 0.5mm at every direction; Probe less than 3mm in mesial and distal; Get a written consent from the patient
Exclusion criteria: Existence of systemic disease; Lactation and pregnancy; Sensitivity to lidocaine; Absence of pulp exposure after decay removal; Errors during endodontic treatment
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Not 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 Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2017-02-18, 1395/11/30
Ethics committee reference number
IR.SBMU.RIDS.1395.357
Health conditions studied
1
Description of health condition studied
symptomatic irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
pain
Timepoint
4,8,24 and 48 hours after treatment
Method of measurement
with visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
low level laser irradiation after treatment in first subgroup of experimental group: in this subgroup low level irradiation (Diode 808nm) will be done once for 80 seconds on buccal mucosa covering mesial and distal roots of the tooth.
Category
Treatment - Other
2
Description
low level laser irradiation after treatment in second subgroup of experimental group: in this subgroup low level irradiation (Diode 808nm) will be done twice on both buccal and lingual mucosa covering mesial and distal roots of the tooth for 80 seconds for per side.
Category
Treatment - Other
3
Description
sham irradiation after treatment in placebo group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Moghadas
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Afshin Zarghi
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Dentistry, Shahid Beheshti 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
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Moghadas
Position
Dental student
Other areas of specialty/work
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 910 679 1069
Fax
elhammoghadas@yahoo.comemoghadas@sbmu.ac.ir
Email
elhammoghadas@yahoo.come.moghadas@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Endodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Mandana Naseri
Position
Doctor of Dental Sciences
Other areas of specialty/work
Street address
Department of Endodontics, School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 912 268 5383
Fax
Email
mandana.nasseri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Moghadas
Position
Dental student
Other areas of specialty/work
Street address
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshju Blvd, Evin, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Phone
+98 910 679 1069
Fax
Email
elhammoghadas@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)