Viewing Study NCT06629545



Ignite Creation Date: 2024-10-25 @ 7:48 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06629545
Status: COMPLETED
Last Update Posted: None
First Post: 2024-10-01

Brief Title: The Efficacy of Two Different Irrigation Methods on PGE2 NO and IL-6 Levels
Sponsor: None
Organization: None

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 n30 and SAI n30 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 patients 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 PAI5 AS-PAI-1 if only 1 tooth with PAI 5 and AS-PAI-2 if 2 teeth with PAI 5

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None