Effect of Irrigation-Activation Techniques on Healing in Large Periapical Lesions
NCT ID: NCT06204887
Last Updated: 2025-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
97 participants
INTERVENTIONAL
2021-11-01
2023-05-04
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Manual dynamic activation
Manual dynamic activation
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
Passive ultrasonic activation
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
Laser activation
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.
Non-activated Control
No interventions assigned to this group
Interventions
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Manual dynamic activation
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* Patients the diagnosis of chronic apical periodontitis,
* Periapical index score of 3 and above,
* Patients having good oral hygiene
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Recep Tayyip Erdogan University
OTHER
Responsible Party
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Ahter Sanal Cikman
Assistant Professor
Principal Investigators
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Ahter Şanal Çıkman
Role: PRINCIPAL_INVESTIGATOR
Recep Tayyip Erdogan University
Locations
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Recep Tayyip Erdogan University
Rize, , Turkey (Türkiye)
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2023/35
Identifier Type: -
Identifier Source: org_study_id