The Efficacy of Two Different Irrigation Methods on PGE2, NO and IL-6 Levels

NCT06629545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-08

No results posted yet for this study

Summary

Today, debates about the effectiveness of Passive Ultrasonic Irrigation (PUI) and Sonically Activated Irrigation (SAI) techniques used to increase the success of endodontic treatment in chronic apical periodontitis (AP) are still ongoing.

In this study, the effectiveness of PUI and SAI systems was investigated in AP patients with similar infection burden and periapical lesion size (PLS) based on changes in prostaglandin E2 (PGE2), nitric oxide (NO) and interleukin-6 (IL-6) levels, which are important biomarkers of inflammatory response in gingival crevicular fluid (GCF) samples.

The study was planned as a single-center cross-sectional analytical study. A total of 60 patients with AP requiring root canal treatment \[PUI (n:30) and SAI (n:30)\] and 30 healthy controls were included in the study between January and June 2024. Demographic characteristics of the patients as well as clinical and radiographic findings (PLS and PAI score) were recorded. GCF (preGCF), PGE2, NO and IL-6 levels were measured in all participants before irrigation. The same procedure was repeated in GCF samples 1 week after treatment (postGCF), except for the control group. In addition, 1st order most commonly seen bacteria (FMCB) typing was performed on swab samples taken from the root canals of the patients.

Conditions

  • Apical Periodontitis
  • Inflammatory Markers

Interventions

OTHER

irrigation activation with PUI

The irrigation solution was used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device. The power setting of the ultrasonic device was 30% (VDW Ultra; VDW, Munich, Germany). The tip was activated a total of three times, with each cycle lasting 20 s and involving the use of 1 ml of 2.5% NaOCl. Then, 2 ml of 17% EDTA solution was activated for 1 min as describe above. The ultrasonic tip was placed 1 mm behind the working length without touching the canal walls.

OTHER

irrigation with sonic activation

A suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA) was inserted into the canal 1 mm short of the working length. 3 ml of 2.5% NaOCl solution was activated in three periods of 20 s (1 ml of 2.5% NaOCl in each cycle). Then, the same procedure was repeated with 2 ml of 17% EDTA solution.

Sponsors & Collaborators

  • Istanbul Medipol University Hospital

    lead OTHER

Principal Investigators

  • Seyda Ersahan, Assoc.Prof. · Medipol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-02
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06629545 on ClinicalTrials.gov