An interventional study of irrigation activation with PUI and irrigation with sonic activation in Apical Periodontitis and Inflammatory Markers, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment
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.
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
256 studies on the registry are indexed under Periapical Periodontitis; 65 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 222 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Istanbul Medipol University Hospital is the lead sponsor of 365 studies on the registry; 59 are open to participants now.
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For control group
Exclusion Criteria:
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 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
Pre-treatment GCF (preGCF) samples were collected for all participants
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.
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.
ELISA Analysis of Biochemical Parameters
ELISA assay was performed to measure preGCF and postGCF-PGE2, NO and IL-6 levels
Time frame: Up to 36 weeks
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
Time frame: Up to 36 weeks
Plan to share: Yes — all collected IPD, all IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan
Time frame: starting 6 months after publication
Access criteria: The investigators want to share IPD including all ddPCR and ELISA results with all researchers
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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