Evaluation and Comparison of the Effects of Low-Level Laser Therapy at 810 nm and 660 nm in Reducing Pain After Root Canal Treatment of Maxillary and Mandibular Premolar and Molar Teeth with Irreversible Pulpitis and Apical Periodontitis
Evaluation and Comparison of the Effects of Low-Level Laser Therapy at 810 nm and 660 nm in Reducing Pain After Root Canal Treatment of Maxillary and Mandibular Premolar and Molar Teeth with Irreversible Pulpitis and Apical Periodontitis
Design
This randomized clinical trial is a double-blinded study with a parallel design. This randomized study will be conducted on 28 eligible patients. A simple randomization method will be used for randomization, and participants will be assigned to two intervention groups.
Settings and conduct
This study, which will be conducted at the Faculty of Dentistry, Khorasgan Azad University, is a double-blind study. In this double-blind study, patients are aware of their participation in the study, but the researcher and participants are unaware of the type of laser. In this study, gender, difficulty of root canal treatment, and type of teeth in the lower jaw will be matched, and the type of canal cleaning materials will be the same.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; People with symptomatic apical periodontitis in mandibular and maxillary premolars and molars; Symptomatic irreversible pulpitis; Pain score above 54 before the start of the study
Exclusion criteria: Taking painkillers 48 hours before treatment; Patients presenting for secondary or repeat treatment; People with a history of seizures
Intervention groups
In the first intervention group, patients will receive a low-power laser with a wavelength of 810 nm in addition to standard endodontic treatment.
In the second intervention group, patients will receive a low-power laser with a wavelength of 660 nm in addition to standard endodontic treatment.
Main outcome variables
Pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N266
Registration date:2025-09-30, 1404/07/08
Registration timing:prospective
Last update:2025-09-30, 1404/07/08
Update count:0
Registration date
2025-09-30, 1404/07/08
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-12, 1404/07/20
Expected recruitment end date
2025-12-11, 1404/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation and Comparison of the Effects of Low-Level Laser Therapy at 810 nm and 660 nm in Reducing Pain After Root Canal Treatment of Maxillary and Mandibular Premolar and Molar Teeth with Irreversible Pulpitis and Apical Periodontitis
Public title
Comparison of the Effects of Low-Level Laser Therapy at 810 nm and 660 nm in Reducing Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
People with symptomatic apical periodontitis in mandibular and maxillary premolars and molars
Symptomatic irreversible pulpitis
Pain score above 54 before the start of the study
Exclusion criteria:
Taking painkillers 48 hours before treatment
Pregnant or breastfeeding women
Patients presenting for secondary or repeat treatment
People with a history of seizures
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random method. 28 cards are selected and numbers from 1-28 are inserted on the cards. The cards are placed in an envelope. Two of the design partners take one card out of the envelope each time and announce the card number. Paired numbers are assigned to the intervention group and odd numbers to the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, patients are aware of their participation in the study, but the researcher and participants are unaware of the type of laser. To maintain the two -blind conditions, the laser devices used in appearance and function sound were fully similar to that patients could not detect the type of laser. Disclosure tags and symptoms were hidden on the devices, and each device's settings were made by a technique that was neither associated with patients nor involved in evaluating the results.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2025-07-07, 1404/04/16
Ethics committee reference number
IR.IAU.KHUISF.REC.1404.307
Health conditions studied
1
Description of health condition studied
Symptomatic apical periodontitis
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Pain level
Timepoint
At baseline, immediately after treatment, and at 4, 8, 12, and 24 hours after treatment
Method of measurement
Using a visual pain scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, patients will receive a low-power laser with a wavelength of 810 nm in addition to standard endodontic treatment.
Category
Treatment - Other
2
Description
In the second intervention group, patients will receive a low-power laser with a wavelength of 660 nm in addition to standard endodontic treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Anahita Alikhani
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
Anahitaalkh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Khorasgan Branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Khorasgan Branch
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
Islamic Azad University, Khorasgan branch
Full name of responsible person
Anahita Alikhani
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4003
Email
Anahitaalkh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Dr. Amir Mansour Shirani
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4053
Email
am_shirani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Dr. Amir Mansour Shirani
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8595158
Phone
+98 31 3535 4053
Email
am_shirani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD