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The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP) (PP)

Primary Purpose

Post-operative Pain, Apical Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EDDY
Diode Laser device
Conventional irrigation
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring diode laser, EDDY, post-operative pain, sypmtomatic apical periodontitis

Eligibility Criteria

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

Inclusion Criteria:

  1. Healthy adult patients aged between 18 and 65 years
  2. Moderate to severe pain (4-10) according to a visual analogue scale (VAS)
  3. Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation)

Exclusion Criteria:

  1. Pregnancy or lactation
  2. Taking analgesics or anti-inflammatory drugs 12 hours before the treatment
  3. Taking antibiotics in the month prior to the treatment
  4. Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex
  5. Allergy to articaine or non-steroid anti-inflammatory drugs

Sites / Locations

  • Biruni University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 (conventional irrigation)

Group 2 (EDDY)

Group 3 (conventional irrigation and laser irradiation)

Group 4 (EDDY and laser irradiation)

Arm Description

After finishing the mechanical instrumentation, each root canal was irrigated with 5 ml of 5.25% NaOCl using a 31-gauge needle positioned 2 mm shorter than the WL. To remove the smear layer, 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) was used in each canal for 1 minute, and 5 ml of saline was then administered to neutralize all the residues.

In group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1.

In group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power.

In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2.

Outcomes

Primary Outcome Measures

Post-operative pain
Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure
Anaglesic intake
After the operation nalgesic intake and time intervals were recorded

Secondary Outcome Measures

Full Information

First Posted
January 4, 2022
Last Updated
January 4, 2022
Sponsor
Biruni University
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1. Study Identification

Unique Protocol Identification Number
NCT05195021
Brief Title
The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)
Acronym
PP
Official Title
The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain in Mandibular Molars With Symptomatic Apical Periodontitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Aim: The aim of this study was to examine post-operative pain (PP) severity after conventional irrigation and sonic activation methods, with and without laser disinfection in mandibular molar teeth diagnosed with symptomatic apical periodontitis. Methods: In total, 80 patients with symptomatic apical periodontitis were included in this randomized clinical study. There were four different irrigation and disinfection groups. In group 1, conventional irrigation only was applied. In group 2, EDDY (VDW, Munich, Germany), a sonic irrigation activation system, was applied. In groups 3 and 4, irradiation with a 980-nm diode laser was performed, following irrigation with the conventional method (needle irrigation) and EDDY (VDW) irrigation system, respectively. PP was assessed using a visual analogue scale (VAS). The patients were instructed to record their PP using this scale 8, 24, 48 hours and 7 days post-procedure, in addition to their analgesic intake. A chi-square test, Fisher's exact chi-square test and Fisher-Freeman-Halton exact test were used to assess qualitative data. Inter-group and intra-group parameters were assessed using the Kruskal-Wallis test and Wilcoxon's test at a significance level of p < 0.05 (for both).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Apical Periodontitis
Keywords
diode laser, EDDY, post-operative pain, sypmtomatic apical periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (conventional irrigation)
Arm Type
Experimental
Arm Description
After finishing the mechanical instrumentation, each root canal was irrigated with 5 ml of 5.25% NaOCl using a 31-gauge needle positioned 2 mm shorter than the WL. To remove the smear layer, 5 ml of 17% ethylenediaminetetraacetic acid (EDTA) was used in each canal for 1 minute, and 5 ml of saline was then administered to neutralize all the residues.
Arm Title
Group 2 (EDDY)
Arm Type
Experimental
Arm Description
In group 2, 1 ml of 5.25% NaOCl was agitated for 20 seconds three times with the EDDY tip positioned 2 mm shorter than the WL. The root canals were then irrigated with 2 ml of 5.25% NaOCl again. Subsequently, the EDDY tip was activated with short pumping movements, and 2 ml of 17% EDTA was activated for 30 seconds, as described above. The final irrigation followed the same procedures as in group 1.
Arm Title
Group 3 (conventional irrigation and laser irradiation)
Arm Type
Experimental
Arm Description
In group 3, final irrigation followed the same procedures as in group 1 and group 2. During the laser therapy, both the operator and the patient wore eyewear for protection. Laser irradiation was performed using a 980-nm diode laser (Medency Primo 10 W Diode Laser; Vicenza, Italy), coupled with optical fibre (200 µm). The settings were as follows: average power of 1.2 W with a low frequency of 50 Hz and energy of 12 J (each cycle) in pulsed mode, irradiation for 10 seconds, followed by a 10 second pause, which constituted one cycle. This cycle was applied four times to each root canal. The optical fibre tip was located at the WL. The root canals were then slowly (at a speed of 2 mm/s) irradiated from the apical to the coronal portion using a continuous helicoidal movement, with optical fibre tip contacting the root canal walls in one cycle for each power.
Arm Title
Group 4 (EDDY and laser irradiation)
Arm Type
Experimental
Arm Description
In this group, after agitation using the EDDY (VDW) system was performed using the same procedures as in group 3, final irrigation and laser irradiation were done as in group 2.
Intervention Type
Device
Intervention Name(s)
EDDY
Other Intervention Name(s)
EDDY (VDW, Munich, Germany)
Intervention Description
EDDY (VDW) sonic irrigation activation system
Intervention Type
Device
Intervention Name(s)
Diode Laser device
Other Intervention Name(s)
Medency Primo 10 W Diode Laser, Vicenza, Italy
Intervention Description
980-nm diode laser device
Intervention Type
Device
Intervention Name(s)
Conventional irrigation
Other Intervention Name(s)
31-guage side port needle (NaviTip; Ultradent, South Jordan, UT)
Intervention Description
Conventional root canal irrigation with 31-guage side port needle
Primary Outcome Measure Information:
Title
Post-operative pain
Description
Post-operative pain levels in each group were assessed by visual analog scale (VAS) The pain levels were evaluated at 8, 24, 48 hours and 7 days post-procedure
Time Frame
7 days
Title
Anaglesic intake
Description
After the operation nalgesic intake and time intervals were 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 adult patients aged between 18 and 65 years Moderate to severe pain (4-10) according to a visual analogue scale (VAS) Mandibular molar teeth diagnosed with symptomatic apical periodontitis (a painful response during mastication and/or percussion or palpation) Exclusion Criteria: Pregnancy or lactation Taking analgesics or anti-inflammatory drugs 12 hours before the treatment Taking antibiotics in the month prior to the treatment Teeth with calcified root canals, greater than grade I mobility and a 4 mm pocket depth, non-restorable damage, occlusal trauma and previous root canal treatment or an open apex Allergy to articaine or non-steroid anti-inflammatory drugs
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.

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The Effect of Different Irrigation and Disinfection Methods on Post-operative Pain (PP)

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