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Completed

NCT Number: NCT07005219

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Esenler, 34230, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Reduction in Bacterial Load

    Time frame: During operation.

    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).

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

Efficacy of Minimal vs. Conventional Apical Preparation With Passive Ultrasonic Irrigation in Reducing Intracanal Bacteria: A Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 5, 2025
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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