Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis

Effect of Root Canal Disinfection With 980 µm Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis: A Randomized Clinical Trial

Aim: This study aims to assess the effect of root canal disinfection with a 980 µm diode laser following chemomechanical root canal preparation on the severity of pain after root canal treatment (RCT).

Materials and Methods: In present study, asymptomatic, single-rooted teeth with periapical index (PAI) score 3 or 4 were included. All patients were treated with two visits of root canal treatment including dressing with calcium hydroxide. Patients were randomly divided into two groups (n: 28). 'Control (no laser)': The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA and 5 ml distilled water. 'Laser Disinfection (LD)': Root canals were irradiated with 980 µm diode laser after final irrigation at both visits. The pain levels were evaluated using visual analog scale (VAS) after 8, 24, 48 hours and 7 days. In addition, analgesic intake and time intervals were recorded by patients. The collected data were statistically analyzed with the Chi-square and Mann-Whitney U test (p<0.05).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Apical Periodontitis
• Intervention / Treatment: Procedure: 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),; Device: Medency Primo Diode Laser Device (Medency, Vicenza, Italy)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34010
    • Biruni University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy patients
• Patients that had asymptomatic, single-rooted teeth with PAI score 3 or 4

Exclusion Criteria:

• antibiotic use with in the last month,
• anti-inflammatory analgesic use within the last five days,
• systemic disorder, pregnancy or lactation,
• traumatic occlusion,
• presence of other teeth requiring RCT,
• teeth with root canal fillings,
• calcified canals,
• root resorption,
• periodontal diseases,
• sinus tracts
• severe crown destruction preventing rubber-dam application

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control (No Laser) Group; The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.	Procedure: 2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),; Final conventional irrigation
Experimental: Laser Disinfection (LD) Group; After final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water, root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle. This cycle was applied 4 times for each root canal. The optical fiber (Medency) was inserted 1 mm short of the apex and the root canals were slowly (at a speed of 2mm/s) irradiated from apical to coronal in continuous circling movements to treat all dentinal tubules in one cycle for each power.	Device: Medency Primo Diode Laser Device (Medency, Vicenza, Italy); Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain	Post-operative pain levels in each group will be assessed by visual analog scale (VAS).The pain levels will be evaluated after 8, 24, 48 hours and 7 days.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic intake	After first and second appointments, analgesic use and time intervals will be recorded.	7 days

Collaborators and Investigators

• Sponsor: Biruni University
• Investigators: Principal Investigator: Sema Sönmez Kaplan, DDS, PhD, Biruni University

Publications and helpful links

General Publications

• Kaplan T, Sezgin GP, Sonmez Kaplan S. Effect of a 980-nm diode laser on post-operative pain after endodontic treatment in teeth with apical periodontitis: a randomized clinical trial. BMC Oral Health. 2021 Jan 22;21(1):41. doi: 10.1186/s12903-021-01401-w.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2019
• Primary Completion (Actual): November 2, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: root canal treatment; post-operative pain; visual analog scale; diode laser; irrigation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Pain, Postoperative; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: BİRUNİ-BAP-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Not decided which collected IPD or which IPD that underlie results to share in a publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No