Clinical Trials Directory

Trials / Completed

CompletedNCT06204887

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
97 (actual)
Sponsor
Recep Tayyip Erdogan University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREManual dynamic activationThe 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.
PROCEDUREPassive ultrasonic activationA 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.
PROCEDURELaser activationA 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.

Timeline

Start date
2021-11-01
Primary completion
2023-02-27
Completion
2023-05-04
First posted
2024-01-12
Last updated
2025-12-24
Results posted
2025-05-25

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT06204887. Inclusion in this directory is not an endorsement.