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

NCT06204887 | Completed Results

• 1 other identifier: 2023/35
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Effect of Irrigation Activation on Periapical Healing

Keywords

Irrigation activation; periapical healing

Outcome Measures

Primary Outcomes (2)

• Percentage Change in Lesion Volume at 12-months Follow-up

  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.

  One year from the beginning of the study

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

  One year from the beginning of the study

Study Arms (4)

Manual dynamic activation

EXPERIMENTAL

Procedure: Manual dynamic activation

Passive ultrasonic activation

EXPERIMENTAL

Procedure: Passive ultrasonic activation

Laser activation

EXPERIMENTAL

Procedure: Laser activation

Non-activated Control

NO INTERVENTION

Interventions

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.

Passive ultrasonic activation

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.

Laser activation

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.

Manual dynamic activation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdogan University

Rize, Turkey (Türkiye)

Location

Limitations and Caveats

The follow-up period of the study was 1 year, which may have limited our ability to obtain definitive evidence of lesion changes in the long term.

Results Point of Contact

• Title: Dr. Ahter Şanal Çıkman
• Organization: Recep Tayyip Erdogan University

ahter.sanalcikman@erdogan.edu.tr

05069293341

Study Officials

• Ahter Şanal Çıkman

  Recep Tayyip Erdogan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: November 1, 2021
• Primary Completion: February 27, 2023
• Study Completion: May 4, 2023
• Last Updated: December 24, 2025
• Results First Posted: May 25, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)