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

Comparison of Passive Ultrasonic and Sonically Activated Irrigation Methods in the Treatment of Apical Periodontitis: Evaluation of PGE2, NO and IL-6 Levels

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.

Study Overview

• Status: Completed
• Conditions: Apical Periodontitis; Inflammatory Markers
• Intervention / Treatment: Other: irrigation activation with PUI; Other: irrigation with sonic activation

Detailed Description

The diagnosis was established according to the patient's history, clinical inspection including palpation, tenderness to percussion, pulpal sensitivity testing, and radiographic examination. Demographic characteristics of the participants (age, gender, chronic disease status, etc.) as well as clinical and radiographic findings [pain level, number of crowns (NC), number of fillings (NF), number of root canal fillings (NRC), and number of missing teeth (NMT)] were recorded. Panoramic and periapical dental radiographs were taken. The presence of radiolucent images associated with the periapical region and radiographic bone loss were evaluated. Radiographs were examined with the help of Kodak Dental Imaging Software. The presence of periapical radiolucency without periodontal disease was considered sufficient criteria for the diagnosis of AP. The largest diameter of the lesion was measured on preoperative periapical radiographs and recorded as periapical lesion size (PLS). In addition, periapical index (PAI) score defined by Ørstavik et al (Ørstavik et al., 1986) and abscess scoring based on the periapical index (AS-PAI) were recorded for patients with AP. AS-PAI was determined as follows: AS-PAI-0 if PAI<5, AS-PAI-1 if only 1 tooth with PAI 5 and AS-PAI-2 if >2 teeth with PAI 5

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Esenler
    • Istanbul, Esenler, Turkey
      • Istanbul Medipol University Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

For control group

• People who come for a check-up, are healthy in terms of dental and periodontal health, do not have any systemic acute or chronic disease (such as infection, kidney disease, cardiovascular disease, inflammatory and rheumatic disease, diabetes and local or widespread tissue damage) and have similar values in terms of gender, age and weight to the study groups, For experimental groups
• Being systemically healthy,
• Patients between the ages of 18-65,
• Those having a PAI score of 3-5 For both study and control groups
• The volunteer wishes to participate in the research by signing the 'Informed Consent Form'.

Exclusion Criteria:

• Those who have used nonsteroidal anti-inflammatory drugs and/or immunosuppressive drugs, steroids in the last 48 hours as this may affect the test results, and those who have a history of using high doses of biotin vitamin as this may affect the test results,
• Those who were either pregnant, lactating, morbidly obese, presence of malignancy, presence of concomitant infection other than AP, presence of acute or chronic inflammatory disease,
• Those with periodontal disease (with periodontal pockets and attachment levels exceeding 4 mm.),
• Those having inadequate crown structures for isolation with a rubber dam,
• Those with a history of previous endodontic treatment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive ultrasonic irrigation; The irrigation solution was agitated by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device.	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.
Experimental: Sonic activated irrigation; The irrigation solution was agitated by a suitable-size activator tip (#25/.04) attached to an EndoActivator sonic handpiece (Dentsply Tulsa Dental Specialties, Tulsa, OK, USA).	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.
No Intervention: Control group; Pre-treatment GCF (preGCF) samples were collected for all participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ELISA Analysis of Biochemical Parameters	ELISA assay was performed to measure preGCF and postGCF-PGE2, NO and IL-6 levels	Up to 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genomic DNA isolation and measurement of DNA concentration	Pretreatment bacteria number and bacteria species of samples taken from root canals measured via PCR and Sanger sequencing	Up to 36 weeks

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital
• Investigators: Principal Investigator: Seyda Ersahan, Assoc.Prof., Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2023
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): April 1, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: IL-6; Gingival crevicular fluid; apical periodontitis; passive ultrasonic irrigation; Sonically Activated Irrigation; PGE
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis
• Other Study ID Numbers: 2023 (GRAMMY Museum Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: starting 6 months after publication
• IPD Sharing Access Criteria: The investigators want to share IPD including all ddPCR and ELISA results with all researchers
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

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