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

NCT06629545 | Completed

• 1 other identifier: 2023
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

apical periodontitis; passive ultrasonic irrigation; Sonically Activated Irrigation; Gingival crevicular fluid; PGE; IL-6

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Genomic DNA isolation and measurement of DNA concentration

  Up to 36 weeks

Study Arms (3)

Passive ultrasonic irrigation

EXPERIMENTAL

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

Sonic activated irrigation

EXPERIMENTAL

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

Control group

NO INTERVENTION

Pre-treatment GCF (preGCF) samples were collected for all participants

Interventions

irrigation activation with PUI OTHER

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.

Passive ultrasonic irrigation

irrigation with sonic activation OTHER

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.

Sonic activated irrigation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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\'.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Seyda Ersahan, Assoc.Prof.

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Seyda Ersahan, Clinical Associate Professor

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 8, 2024
• Study Start: August 2, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: starting 6 months after publication
• Access Criteria: The investigators want to share IPD including all ddPCR and ELISA results with all researchers

Locations

TU (1)