NCT05195021: PP

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

Completed NA Last updated 18 January 2022

What this trial tests

NA trial testing EDDY in Post-operative Pain in 80 participants. Completed in 30 July 2021.

Timeline

1 December 2020

Primary endpoint
30 June 2021

30 July 2021

Quick facts

Lead sponsor	Biruni University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 December 2020
Primary completion	30 June 2021
Estimated completion	30 July 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• EDDY
• Diode Laser device
• Conventional irrigation

Conditions studied

• Post-operative Pain — all drugs for Post-operative Pain →
• Apical Periodontitis — all drugs for Apical Periodontitis →

Sponsor

Biruni University

Who can join

Adults 18 to 65, any sex, with Post-operative Pain or Apical Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effect of different irrigation and disinfection methods on post-operative pain in mandibular molars: a randomised clinical trial.
   Kaplan T, Kaplan SS, Sezgin GP. · · 2022 · cited 6× · PMID 36514017 · DOI 10.1186/s12903-022-02651-y