Efficacy of Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria

NCT07005219 | Completed DMC

• 1 other identifier: 10840098-772.02-6513
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates intracanal bacterial load in molar teeth with chronic apical periodontitis before and after root canal shaping with two different apical enlargement sizes and ultrasonic irrigation activation.

Conditions

Periapical Periodontitis; Root Canal Infection

Keywords

apical periodontitis; irrigation activation; apical enlargement; ddPCR; bacterial species

Outcome Measures

Primary Outcomes (1)

• Reduction in Bacterial Load

  Quantitative reduction in bacterial load in the mesial root canals of mandibular molars with apical periodontitis, as measured by Droplet Digital PCR (ddPCR), following different apical enlargement sizes and passive ultrasonic irrigation activation, provides quantitative data that can be statistically analyzed to compare the two intervention groups (#25/0.4 vs. #35/0.4 apical enlargement).

  During operation.

Study Arms (2)

Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping)

EXPERIMENTAL

Intervention: * Root canal shaping using One Curve Mini #25/0.4 rotary file. * Irrigation with 3% NaOCl. * Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device. * 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle). * Ultrasonic tip placed 2 mm short of working length, without contacting canal walls.

Procedure: Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation

Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping)

EXPERIMENTAL

Intervention: * Root canal shaping using One Curve Mini #35/0.4 rotary file. * Irrigation with 3% NaOCl. * Passive Ultrasonic Irrigation (PUI) using IRRI S 21/25 tip on VDW Ultra device. * 3 cycles of ultrasonic activation (each 20 seconds, 1 ml NaOCl per cycle). * Ultrasonic tip placed 2 mm short of working length, without contacting canal walls.

Procedure: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation

Interventions

Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation PROCEDURE

Participants in this group underwent root canal shaping using a One Curve Mini #25/0.4 rotary file. After mechanical preparation, passive ultrasonic irrigation (PUI) was performed using a VDW Ultra device with an IRRI S 21/25 ultrasonic tip. Irrigation was activated with 3% sodium hypochlorite (NaOCl) in three 20-second cycles, using 1 ml per cycle. The ultrasonic tip was placed 2 mm short of the working length without contacting canal walls.

Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping)

Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation PROCEDURE

Participants in this group underwent root canal shaping using a One Curve Mini #35/0.4 rotary file. The same passive ultrasonic irrigation protocol was applied as in Arm 1, using 3% NaOCl in three 20-second cycles with 1 ml per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.

Apical Enlargement with One Curve Mini #35/0.4 (Conventional Shaping)

Eligibility Criteria

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

You may qualify if:

• a non-contributory medical history
• must have an asymptomatic mandibular molar with periapical lesions of\>2.0x2.0 mm around the mesial roots
• must be diagnosed as chronic apical periodontitis

You may not qualify if:

• Patients with acute clinical symptoms
• Teeth with previous root canal treatment
• non-restorable teeth

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Esenler, 34230, Turkey (Türkiye)

Location

Related Publications (1)

• Yavuz M, Eyuboglu TF, Eroglu SE, Hepsenoglu YE. The effect of apical preparation size and passive ultrasonic activation on microbial load in root canals with periapical lesions. Sci Rep. 2025 Dec 6;16(1):1264. doi: 10.1038/s41598-025-30950-1.

  PMID: 41350378 DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Melike Yavuz

  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: Director, Clinical Research

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 5, 2025
• Study Start: February 24, 2024
• Primary Completion: July 8, 2024
• Study Completion: November 27, 2024
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After its publication in a journal, we want to share our data.

Locations

TU (1)