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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07005219
Enrollment
24
Registered
2025-06-05
Start date
2024-02-24
Completion date
2024-11-27
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Periodontitis, Root Canal Infection

Keywords

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

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.

Interventions

PROCEDURERoot 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.

PROCEDURERoot 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.

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduction in Bacterial LoadDuring 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).

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026