search
Back to results

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

Primary Purpose

Apical Periodontitis, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Medency Primo Diode Laser Device (Medency, Vicenza, Italy)
2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apical Periodontitis focused on measuring diode laser, irrigation, post-operative pain, root canal treatment, visual analog scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control (No Laser) Group

Laser Disinfection (LD) Group

Arm Description

The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Analgesic intake
After first and second appointments, analgesic use and time intervals will be recorded.

Full Information

First Posted
July 15, 2020
Last Updated
July 22, 2020
Sponsor
Biruni University
search

1. Study Identification

Unique Protocol Identification Number
NCT04486196
Brief Title
Effect of Diode Laser on Post-operative Pain After Endodontic Treatment in Teeth With Apical Periodontitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
November 2, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apical Periodontitis, Postoperative Pain
Keywords
diode laser, irrigation, post-operative pain, root canal treatment, visual analog scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control (No Laser) Group
Arm Type
Experimental
Arm Description
The final irrigation was performed using 5ml 2.5% NaOCI, followed by 5 ml 17% EDTA for 3 min and 5 ml distilled water.
Arm Title
Laser Disinfection (LD) Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Medency Primo Diode Laser Device (Medency, Vicenza, Italy)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),
Intervention Description
Final conventional irrigation
Primary Outcome Measure Information:
Title
Post-operative pain
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Analgesic intake
Description
After first and second appointments, analgesic use and time intervals will be recorded.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sema Sönmez Kaplan, DDS, PhD
Organizational Affiliation
Biruni University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biruni University
City
İstanbul
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not decided which collected IPD or which IPD that underlie results to share in a publication.
Citations:
PubMed Identifier
33482797
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs