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Completed

NCT Number: NCT06204887

Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions

The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.

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Key information

Conditions

Effect of Irrigation Activation on Periapical Healing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

About this study

The aim of this study was to highlight the healing rates of large periapical lesions after different irrigation activation treatments as manual dynamic activation (MDA), passive ultrasonic irrigation (PUI), shock wave-enhanced emission photoacoustic streaming (SWEEPS) using CBCT scans based on volumetric change analysis during 1-year follow-up.

A total of 56 systemically healthy male/female patients with mandibular single-rooted teeth with a periapical index score (PAI) of 3 or higher were included in the study. Pretreatment lesion volumes were determined by CBCT. Patients were randomly divided into 3 study groups (PUI, SWEEPS, MDA) and control group (n=14). For the follow-up routine, 2D radiographs were taken at months 3, 6, and 9, as well as clinical examinations. At the end of 12 months, 3D evaluation of lesion volumes was performed using ITK SNAP. Pretreatment and follow-up values were statistically analyzed with the Wilcoxon test.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients having single root mandibular teeth
  • Patients the diagnosis of chronic apical periodontitis,
  • Periapical index score of 3 and above,
  • Patients having good oral hygiene

Exclusion criteria

  • Patients with systemic diseases (diabetes, hypertension, chronic liver disease, coagulation disorders),
  • Patients with bone metabolism disease and/or
  • Patients using drugs that affect bone metabolism (such as steroids, bisphosphonates)
  • Patients with a history of radiotherapy
  • Pregnant patients
  • Teeth with mobility of 2 or more, periodontal pocket depth of 5 mm or more, generalized chronic periodontitis, internal and external resorption, and/or vertical and horizontal root fractures

Treatment and study plan

Manual dynamic activation

Procedure

The root canals were filled with irrigation solutions. A main gutta percha cone was positioned 1 mm shorter than the working length and 2 mm coronal-apical direction movement was performed at a rate of 100 strokes per minute during 60 s.

passive ultrasonic activation

Procedure

A non-cutting ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) coupled to an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China) (mode: E, setting: 6) was used according to the manufacturer's recommendations.

Laser activation

Procedure

A 2940 nm Er:YAG-laser device (Lightwalker, Fotona, Ljubljana, Slovenia), equipped with a handpiece (H14, Fotona) holding a 8.5 mm long and 600 µm diameter-tapered fiber tip (SWEEPS 600, Fotona) was used for irrigation activation. The device was set to AutoSWEEPS mode with two ultrashort micropulse durations (25 μs) continuously varying at 0.3 W, 20 mJ, 15 Hz settings. The air and water sprays were turned off.

Primary outcomes

  1. Percentage Change in Lesion Volume at 12-months Follow-up

    Time frame: One year from the beginning of the study

    3D volumes pre-operatively and at the end of 1 year were measured using the segmentation technique by slicing the image at 0.09 mm intervals. The borders of the lesion were determined with gray scale. The defined volume boundaries were automatically filled by bubbles until the entire defect was filled completely. If necessary, manual correction was applied at this stage of lesion volume measurements, allowing for small individual additions or subtractions. At the end, the well-defined size of the lesion could be visualized in 3D. After finishing the process, the software depicted the exact volume of the defects in mm3.The volume data were compared with the preoperative CBCT measurements in each case. The primary healing of the periapical tissues was assessed, volume changes were measured, and the long-term outcomes of the procedures were compared using percentage of the lesion volume change.

  2. Distribution of Lesion Status in Different Irrigation Groups at 12-year Follow-up

    Time frame: One year from the beginning of the study

Sponsors and collaborators

Lead sponsor

Recep Tayyip Erdogan University

Other

Registry information

Official study title

Evaluation of Different Irrigation-Activation Techniques on Healing Outcome of Large Periapical Lesions: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 12, 2024
Registry last updated
Dec 24, 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.