Clinical trial NCT06629545: The Efficacy of Two Different Irrigation Methods on PGE2, NO and IL-6 Levels
Official title: Comparison of Passive Ultrasonic and Sonically Activated Irrigation Methods in the Treatment of Apical Periodontitis: Evaluation of PGE2, NO and IL-6 Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Apical Periodontitis
Inflammatory Markers
Keywords: apical periodontitis
passive ultrasonic irrigation
Sonically Activated Irrigation
Gingival crevicular fluid
PGE
IL-6
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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 \&amp;amp;#39;Informed Consent Form\&amp;amp;#39;.

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.

Primary outcomes:
measure: ELISA Analysis of Biochemical Parameters
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: Genomic DNA isolation and measurement of DNA concentration
timeFrame: Up to 36 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Faculty of Dentistry
state: Esenler
Study officials:
affiliation: Medipol University
name: Seyda Ersahan, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: