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

M

Medipol University

Status

Completed

Conditions

Root Canal Infection
Periapical Periodontitis

Treatments

Procedure: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation
Procedure: Root canal shaping with One Curve Mini #25/0.4 and passive ultrasonic irrigation

Study type

Interventional

Funder types

Other

Identifiers

NCT07005219
10840098-772.02-6513

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

24 participants in 2 patient groups

Apical Enlargement with One Curve Mini #25/0.4 (Minimal Invasive Shaping)
Experimental group
Description:
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.
Treatment:
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 group
Description:
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.
Treatment:
Procedure: Root canal shaping with One Curve Mini #35/0.4 and passive ultrasonic irrigation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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