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Effects of Irrigation Activation Systems on Postoperative Pain and Lesion Healing in Single-Visit Retreatment

NCT07150585 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-05

No results posted yet for this study

Summary

In this superiority randomized clinical trial with a parallel design, 75 asymptomatic maxillary anterior teeth with 2-5 mm periapical lesions and a history of primary root canal treatment (PRCT) at least four years earlier were included. Patients were randomly assigned, using a randomization sequence generated on www.random.org, and divided into three groups. In all patients, existing canal fillings were removed using Remover rotary file (Coltene, MicroMega) and hand files. Working lengths were determined with an apex locator and canals reshaped using the step-back technique. For the final irrigation, side-vented needles were positioned 2 mm short of the working length. Activation was performed with Ultra X (Eighteeth) in the ultrasonic group, EDDY (VDW) in the sonic group, and an Er:YAG laser (LightWalker, Fotona) in SWEEPS mode (2940 nm, 5 μs, 20 mJ, 15 Hz) in the laser group. In all groups, each irrigant (EDTA followed by NaOCl) was activated in three cycles of 20 seconds. All canals were obturated with gutta-percha and a bioceramic sealer, and restored with composite. Pain levels were recorded using the Visual Analog Scale (VAS) 0, 6, 12, 24, 48, and 72 hours, and on day 7. The completed forms were collected by another independent investigator blinded to the group assignments. At the end of the treatment, periapical radiographs were obtained and recorded from all patients. Patients whose treatment was completed will be recalled at the 6th, 12th, and 24th months for follow-up periapical radiographs, and the comparison of healing among the groups will be evaluated as a secondary outcome based on changes in the PAI index.

Conditions

  • Retreatment
  • Asymptomatic Apical Periodontitis

Interventions

DEVICE

Ultrasonic Activation Group

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using the Ultra X device (Eighteeth) with ultrasonic tips.

DEVICE

Sonic Activation Group

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using an EDDY sonic activation tip (VDW, Munich, Germany)

DEVICE

Laser Activation Group

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using the LightWalker (Fotona, Ljubljana, Slovenia) Er:YAG laser device in SWEEPS mood

Sponsors & Collaborators

  • Ege University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-06-01
Completion
2027-06-01

Countries

  • Turkey (Türkiye)

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150585 on ClinicalTrials.gov