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

NCT ID: NCT07005219

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-24
• Study Completion Date: 2024-11-27

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.

Detailed Description

This randomized controlled clinical trial investigated the effect of different apical enlargement sizes and passive ultrasonic irrigation (PUI) on the bacterial load in the mesial roots of mandibular molars diagnosed with chronic apical periodontitis. The study was conducted at Istanbul Medipol University Faculty of Dentistry, Endodontics Clinic, and included 24 patients who required primary root canal treatment and exhibited clinical and radiographic signs of chronic apical periodontitis.

Participants were randomly assigned to two groups (n=12 each). In Group 1, root canal shaping was performed using a One Curve Mini #25/0.4 rotary file. In Group 2, shaping was performed using a One Curve Mini #35/0.4 rotary file. In both groups, passive ultrasonic irrigation was applied using the VDW Ultra device with an IRRI S 21/25 ultrasonic tip. The irrigation protocol consisted of three 20-second cycles using 1 ml of 3% sodium hypochlorite (NaOCl) per cycle. The ultrasonic tip was positioned 2 mm short of the working length without contacting the canal walls.

Bacterial samples were collected from the mesial root canals during the treatment. The bacterial load was quantified using Droplet Digital PCR (ddPCR), a highly sensitive and precise molecular technique that allows absolute quantification of bacterial DNA. This method was chosen because it enables accurate detection of bacterial reduction following the interventions.

Conditions

Periapical Periodontitis; Root Canal Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 #35/0.4 (Conventional Shaping)

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

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

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Melike Yavuz

Director, Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melike Yavuz

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Esenler, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

10840098-772.02-6513

Identifier Type: -

Identifier Source: org_study_id