Protocol summary

Study aim
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 double-blind, non-randomized clinical trial with two parallel groups was conducted on 28 patients requiring single-visit root canal treatment. Participants were divided into two groups balanced by gender, each receiving low-level laser therapy at wavelengths of 810 nm or 660 nm alongside standard root canal treatment. Treatments were performed by first-year residents. Analgesic consumption and occurrence of severe pain were recorded, and pain intensity was measured at 4, 8, 12, and 24 hours post-treatment using the Heft-Parker Scale (HPS).
Settings and conduct
Islamic Azad University of Isfahan (Khorasgan)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Patients with irreversible pulpitis and periapical lesion in single-visit root canal treatment of maxillary and mandibular premolars or molars. VAS pain score >54 on the Heft-Parker scale before treatment. Exclusion Criteria:Patients with systemic diseases Pregnant or lactating women Treatment of calcified teeth Patients presenting for secondary treatment or retreatment Patients currently taking anti-inflammatory medications
Intervention groups
F0irst Intervention group: Laser irradiation with a wavelength of 660 nm, power of 100 mW, and energy of 4 J applied for 40 seconds to an area of 1 cm² at the apex of the endodontically treated tooth on the buccal and lingual/palatal sides. Second Intervention group: Laser irradiation with a wavelength of 810 nm, power of 100 mW, and energy of 4 J applied for 40 seconds to an area of 1 cm² at the apex of the endodontically treated tooth on the buccal and lingual/palatal sides.
Main outcome variables
Postoperative Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250923067345N1
Registration date: 2025-10-01, 1404/07/09
Registration timing: registered_while_recruiting

Last update: 2025-10-01, 1404/07/09
Update count: 0
Registration date
2025-10-01, 1404/07/09
Registrant information
Name
Anahita Alikhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 0251
Email address
anahitaalkh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-27, 1404/07/05
Expected recruitment end date
2025-12-26, 1404/10/05
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 Postoperative Pain Following Root Canal Treatment of Maxillary and Mandibular Premolars and Molars with Irreversible Pulpitis Accompanied by Apical Periodontitis
Public title
Evaluation of the Effect of Low-Level Laser Therapy on Reducing Pain After Root Canal Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals with irreversible pulpitis accompanied by symptomatic apical periodontitis in mandibular and maxillary premolars and molars, eligible for single-visit root canal treatment. No use of analgesics within 48 hours prior to treatment. Based on the Heft-Parker (HPS) scale, patients with a pre-treatment VAS score above 54 are included in the study.
Exclusion criteria:
Patients with systemic diseases Pregnant or breastfeeding women Treatment of calcified teeth Patients seeking secondary or retreatment procedures Patients currently taking anti-inflammatory medications
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients: In our study, patients are unaware of which type of laser they receive (810 nm or 660 nm). Data Analyst: The statistician does not know which group received which wavelength and only evaluates the pain levels at different time intervals.
Placebo
Not used
Assignment
Parallel
Other design features
In our study, the effect of two different laser wavelengths on postoperative pain after root canal treatment are evaluated, and no control group is included.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan (Khorasgan) Branch.
Street address
No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan.
City
Esfahan
Province
Isfehan
Postal code
8137999594
Approval date
2025-07-20, 1404/04/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1404.307

Health conditions studied

1

Description of health condition studied
Postoperative pain after root canal treatment in posterior teeth with irreversible pulpitis accompanied by symptomatic apical periodontitis in the maxilla and mandible.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Postoperative Pain
Timepoint
4, 8, 12, and 24 hours after laser irradiation
Method of measurement
Pain intensity will be measured using the Heft-Parker Visual Analog Scale (VAS, HPS).

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Laser irradiation at a wavelength of 660 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the treated tooth, applied to both the buccal and lingual/palatal surfaces.
Category
Treatment - Devices

2

Description
Intervention Group 2: Laser irradiation at a wavelength of 810 nm with a power of 100 W and an energy of 4 J for 40 seconds over an area of 1 cm² at the apex of the endodontically treated tooth, applied to both the buccal and lingual/palatal surfaces.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University of Isfahan (Khorasgan)
Full name of responsible person
Dr. Amir Mansour Shirani
Street address
Islamic Azad University of Isfahan (Khorasgan), Shahid Dr. Mohammad Mahdi Tehranchi Blvd., Arghavanieh, East Jey St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 2900
Email
international@khuisf.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. latifi
Street address
Islamic Azad University of Isfahan (Khorasgan), Shahid Dr. Mohammad Mahdi Tehranchi Blvd., Arghavanieh, East Jey St., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 2900
Email
international@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Isfahan (Khorasgan)
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
Full name of responsible person
Anahita Alikhani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8137999594
Phone
+98 933 197 3330
Email
Anahitaalkh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anahita Alikhani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 21, Esfand Ave., Mehr Ave., Bahar Ave., Farabi 4th Blvd., Sepahan Shahr, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8137999594
Phone
+98 933 197 3330
Email
anahitaalkh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Mansour Shirani
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Islamic Azad University of Isfahan (Khorasgan), Shahid Dr. Mohammad Mahdi Tehranchi Blvd., Arghavanieh, East Jey St., Isfahan, Iran.
City
Esfahan
Province
Isfehan
Postal code
39998-81551
Phone
+98 31 3535 2900
Email
anahitaalkh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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