Effects of Different Irrigation Activation Techniques on the Healing of Large Periapical Lesions

NCT06991803 | Completed Results

• 1 other identifier: MCiçek
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of endodontic treatment is to treat the infection by optimally cleaning the root canal system and precentig reinfection. Root canal preparation must be accompanied by an effective irrigation activation protocol to effectively remove foci of infection. Manual dynamic activation (MDA) is an irrigation activation method performed by up- and downmovements of a gutta-percha compatible with the final instrumentation size.Passive ultrasonic irrigation (PUI) is another activation technique based on the transmission of acoustic energy to the irrigant in the canal through a vibrating file or a thin wire with hydrodynamic activation. Sonic systems create a strong hydrodynamic phenomenon and increase the effectiveness of the solution by using flexible tips connected to special instruments that work with air pressure with low-frequency vibration. Recently, laser activation methods, defined as photon-initiated photoacoustic streaming (PIPS) and shock wave enhanced emission photoacoustic streaming (SWEEPS), which work with conical and radial fiber tips, have been developed. The main difference between PIPS and SWEEPS is that in SWEEPS, the double laser pulse applied to the irrigation solution causes the bubbles to collapse faster, allowing the photoacoustic shock wave to reach deeper into the root canal. Apical periodontitis is a condition in which microbial products in the root canal reach the periapical region, destroy adjacent bone tissue, and is characterized by a radiolucent area in the periradicular region of the affected tooth on a radiograph. Successful healing of apical periodontitis requires a reduction in the size of the radiolucent area and healing of the bone. The periapical index (PAI) system, which grades periapical pathology from 1 to 5 according to increasing radiographic appearance, helps to achieve consensus among clinicians in categorizing lesions. In addition, the healing process of chronic apical periodontitis can be objectively examined via fractal analysis, which can be used to assess the size and density of periapical lesions, the degree of healing of bone tissue, and the remodeling of the trabecular structure quantitatively. The aim of this study was to compare the effects of different irrigation activation methods (MDA, Sonic, PUI, PIPS, and SWEEPS) on healing in single-rooted mandibular premolar teeth with extensive periapical lesions of endodontic origin.

Conditions

Periapical Periodontitis; Irrigation Activation; Lasers

Keywords

Fractal analysis; Irrigation activation; paı; pıps; sweeps; healing of periapical lesion

Outcome Measures

Primary Outcomes (1)

• Post-operative Diameter of the Periapical Lesion

  Post-endodontic treatment, a reduction in the diameter of the periapical lesion may be observed, or the lesion may exhibit complete radiographic resolution. the largest dimension obtained was recorded as the preoperative lesion diameter

  1 year from completion of treatment to follow-up

Secondary Outcomes (1)

• Post-operative Periapical Index (PAI) Score

  1 year from completion of treatment to follow-up

Other Outcomes (1)

• Post-operative Fractal Dimension

  1 year from completion of treatment to follow-up

Study Arms (6)

Control Group (Conventional Syringe Irrigation)

OTHER

In this group, the traditional syringe method was used for final irrigation of the root canals. The canals were irrigated with 6 mL of 17% EDTA solution, 2 mL of saline and, finally, 6 mL of 2.5% NaOCl, and a 30-gauge perforated irrigation needle placed 1-2 mm shorter than the working length was used. During irrigation, 1-2 mm updown movements were made with a constant low pressure.

Other: root canal treatment and irrigation activation

Group 1 (MDA)

EXPERIMENTAL

After the root canal was filled with irrigation solution, a gutta-percha cone compatible with the master file was positioned 1 mm behind the working length and moved up and down with 100 strokes/minute for activation.

Other: root canal treatment and irrigation activation

Group 2 (Sonic Activation)

EXPERIMENTAL

Sonic activation was performed via the Easydo Activator device (EA; Easyinsmile (Weixiaomeichi, Changsha, China). While the solution was present in the canal, the needle tip of the device was placed in the canal 2 mm behind the determined working length, and the solutions were activated at the recommended power setting.

Other: root canal treatment and irrigation activation

Group 3 (PUI)

EXPERIMENTAL

Solutions were activated via ultrasonic tips (mode:E, setting:6) (DTE, Guilin Woodpecker Co., Guilin, Guangxi, China) and an ultrasonic device (DTE S6 Led, Guilin Woodpecker Co., Guilin, Guangxi, China). An ultrasonic tip one size smaller than the master apical file was used 2 mm behind the working length without contacting the walls.

Other: root canal treatment and irrigation activation

Group 4 (PIPS)

EXPERIMENTAL

A Fotona Er:YAG laser device (LightWalker Fotona, Ljubljana, Slovenia) was used for activation. A special conical and radial fiber tip (PIPS 300/14, Fotona) was placed in the coronal part of the pulp chamber, and the irrigation solutions in the canal were activated in SSP mode (50 μs, 0.3 W, 15 Hz and 20 mJ) with the air and water settings turned off.

Other: root canal treatment and irrigation activation

Group 5 (SWEEPS)

EXPERIMENTAL

A Fotona Er:YAG laser device (SWEEPS 600, Fotona) with an 8.5 mm long and 600 µm diameter tapered fiber tip was used for activation. The device was set to SWEEPS mode with two ultrashort micropulses (25 μs) continuously changing at 0.3 W, 20 mJ, and 15 Hz. The tip was placed in the pulp chamber, and the solution was activated with the air and water settings turned off.

Other: root canal treatment and irrigation activation

Interventions

root canal treatment and irrigation activation OTHER

After the teeth were isolated with a rubber dam, the endodontic access cavity was opened. Then, #10-15 K-type hand files were inserted into the canals, and after determining point 0.0 with the electronic apex locator, the working length was determined to be 0.5 mm shorter than this point and confirmed radiographically. When a discrepancy was observed, the apex locator was considered correct. The root canals were prepared with ProTaper Next up to 3 sizes larger than the initial diameter via a torque-controlled endodontic motor in 300 rpm/2-5.2 Ncm rotation mode. Between each file, the canals were irrigated with 5 ml of 2.5% NaOCl. In retreatment cases, after opening the access cavity under rubber dam isolation, the guta percha was removed with RT files, and the rest of the procedure was performed in the same manner as for primary root canal treatment.

Control Group (Conventional Syringe Irrigation); Group 1 (MDA); Group 2 (Sonic Activation); Group 3 (PUI); Group 4 (PIPS); Group 5 (SWEEPS)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who approved the Endodontic Consent Form and Study Participation Form
• Vertucci Class 1 single-rooted mandibular premolars with PAI score of 3 and above, requiring primary endodontic treatment with a diagnosis of apical periodontitis
• Vertucci Class 1 single-rooted mandibular premolars with PAI score of 3 and above, requiring retreatment with a diagnosis of apical periodontitis
• Patients with good oral hygiene

You may not qualify if:

• Immunosuppressive patients
• Pregnant patients
• Those with mobility of 2 and above,
• Those with periodontal pocket depth of 5 mm and above.
• Those with internal and external resorption,
• Those with teeth with vertical and horizontal root fractures

Sponsors & Collaborators

• Recep Tayyip Erdogan University: lead

Study Sites (1)

Recep Tayyip Erdoğan University Faculty of Dentistry Department of Endodontics

Rize, Rize Province, 53020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Results Point of Contact

• Title: Medine Çiçek
• Organization: Recep Tayyip Erdoğan University, Faculty of Dentistry, Department of Endodontics

medinecicekk@hotmail.com

5442745525

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After the preparation was completed, final irrigation was applied via the determined irrigation method. The researchers who conducted the PAI and lesion size evaluations were blinded to the irrigation method and preoperative measurements. Fractal analysis (FA) was performed by an experienced oral and maxillofacial radiologist who was blinded to the activation method and used the fractal box counting method on panoramic radiographs with ImageJ.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: endodontist

Model Details: A Prospective Clinical Study

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 25, 2024
• Last Updated: December 24, 2025
• Results First Posted: December 24, 2025

Record last verified: 2025-12

Locations

TU (1)