Effects of Irrigation Activation Systems on Postoperative Pain and Lesion Healing in Single-Visit Retreatment

NCT07150585 | Active Not Recruiting

• 2 other identifiers: EUDF-ETK- 24-3/86EU-GAP-32275
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In this superiority randomized clinical trial with a parallel design, 75 asymptomatic maxillary anterior teeth with 2-5 mm periapical lesions and a history of primary root canal treatment (PRCT) at least four years earlier were included. Patients were randomly assigned, using a randomization sequence generated on www.random.org, and divided into three groups. In all patients, existing canal fillings were removed using Remover rotary file (Coltene, MicroMega) and hand files. Working lengths were determined with an apex locator and canals reshaped using the step-back technique. For the final irrigation, side-vented needles were positioned 2 mm short of the working length. Activation was performed with Ultra X (Eighteeth) in the ultrasonic group, EDDY (VDW) in the sonic group, and an Er:YAG laser (LightWalker, Fotona) in SWEEPS mode (2940 nm, 5 μs, 20 mJ, 15 Hz) in the laser group. In all groups, each irrigant (EDTA followed by NaOCl) was activated in three cycles of 20 seconds. All canals were obturated with gutta-percha and a bioceramic sealer, and restored with composite. Pain levels were recorded using the Visual Analog Scale (VAS) 0, 6, 12, 24, 48, and 72 hours, and on day 7. The completed forms were collected by another independent investigator blinded to the group assignments. At the end of the treatment, periapical radiographs were obtained and recorded from all patients. Patients whose treatment was completed will be recalled at the 6th, 12th, and 24th months for follow-up periapical radiographs, and the comparison of healing among the groups will be evaluated as a secondary outcome based on changes in the PAI index.

Conditions

Retreatment; Asymptomatic Apical Periodontitis

Keywords

Er:YAG laser; Irrigation activation; Postoperative pain; Sonic irrigation; Ultrasonic irrigation; Single-visit; Nonsurgical endodontic retreatment; outcome of nonsurgical retreatment; periapical lesion healing

Outcome Measures

Primary Outcomes (1)

• Post-operative Pain

  Following single-visit nonsurgical root canal retreatment performed with different irrigation activation techniques, the Visual Analog Scale (VAS) was used to assess and compare the patients' pain levels, and the patients were instructed to record their pain at 0, 6, 12, 24, 48, and 72 hours, as well as on the 7th day. Patients were informed that a score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity.

  From immediately after retreatment to 7 days postoperatively

Secondary Outcomes (1)

• Radiographic healing of periapical lesions

  At 6, 12, and 24 months after retreatment

Study Arms (3)

Ultrasonic Activation Group

ACTIVE COMPARATOR

In the group where passive ultrasonic activation was applied to enhance the efficacy of the final irrigation protocol, an Ultra X device (Eighteeth, Changzhou Sifary Medical Technology Co., Ltd.) equipped with silver 21 mm, 0.2-taper irrigation tips was used. The tip was positioned 2 mm short of the working length and moved in an up-and-down motion to activate 17% EDTA for three 20-second cycles (3 × 2 mL), followed by 2.5% NaOCl for three identical cycles

Device: Ultrasonic Activation Group

Sonic Activation Group

ACTIVE COMPARATOR

In the sonic activation group, a polyamide 20 mm, 0.05 taper EDDY tip (VDW, Munich, Germany) mounted on a sonic air scaler (TA 200, Micron, Japan) was used to enhance the efficacy of the final irrigation protocol. The tip was inserted 2 mm short of the working length and agitated in an up-and-down motion to activate 17% EDTA for three 20-second cycles (3 × 2 mL), followed by 2.5% NaOCl for three identical cycles.

Device: Sonic Activation Group

Laser Activation Group

ACTIVE COMPARATOR

In the laser group, an Er:YAG Lightwalker device (Fotona, Ljubljana, Slovenia) in Shock Wave Enhanced Emission Photoacoustic Streaming (SWEEPS) mode (2940 nm, 20 mJ, 15 Hz, 0.3 W, 25 μs pulse duration) was used. A SWEEPS fiber tip mounted on the H14 handpiece was positioned in the access cavity with air and water pressures set to zero, and was used to activate 17% EDTA for three 20-second cycles (3 × 2 mL), followed by 2.5% NaOCl for three identical cycles.

Device: Laser Activation Group

Interventions

Ultrasonic Activation Group DEVICE

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using the Ultra X device (Eighteeth) with ultrasonic tips.

Also known as: (Ultra X,Eighteeth)

Ultrasonic Activation Group

Sonic Activation Group DEVICE

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using an EDDY sonic activation tip (VDW, Munich, Germany)

Also known as: (EDDY,VDW)

Sonic Activation Group

Laser Activation Group DEVICE

In this group, during single-visit nonsurgical root canal retreatment, irrigant activation in the final irrigation protocol was performed using the LightWalker (Fotona, Ljubljana, Slovenia) Er:YAG laser device in SWEEPS mood

Also known as: (Lightwalker AT,Fotona)

Laser Activation Group

Eligibility Criteria

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

You may qualify if:

• Systemically healthy patients
• Patients between 18 and 65 years of age
• Patients with previously root canal-treated teeth who are asymptomatic
• Patients with maxillary anterior teeth presenting with periapical lesions measuring between 2-5 mm
• Teeth with completed root development and healthy periodontal status
• Patients who agreed to participate in the study

You may not qualify if:

• Patients with any systemic disease
• Pregnant patients
• Patients with allergies to the materials used during the procedure
• Patients with previously root canal-treated teeth who are symptomatic
• Teeth in the maxillary anterior region with periapical lesions smaller than 2 mm or larger than 5.1 mm
• Teeth with open apices
• Teeth with advanced periodontal disease and mobility
• Patients who did not consent to participate in the study

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, Department of Endodontics

Izmır, Bornova, Turkey (Türkiye)

Location

Related Publications (3)

• Mittal N, Baranwal HC, Gupta S, Shankari T, Gupta S, Kharat S. Comparative analysis of reduction in pain scores after single visit root canal treatment using endodontic irrigation protocols, namely, Conventional needle irrigation, PUI, PIPS and SWEEPS: A randomized control trial. J Conserv Dent. 2023 Mar-Apr;26(2):143-149. doi: 10.4103/jcd.jcd_450_22. Epub 2023 Mar 16.

  PMID: 37205889 BACKGROUND

• Liapis D, De Bruyne MAA, De Moor RJG, Meire MA. Postoperative pain after ultrasonically and laser-activated irrigation during root canal treatment: a randomized clinical trial. Int Endod J. 2021 Jul;54(7):1037-1050. doi: 10.1111/iej.13500. Epub 2021 Mar 9.

  PMID: 33595920 BACKGROUND

• Erkan E, Gundogar M, Uslu G, Ozyurek T. Postoperative pain after SWEEPS, PIPS, sonic and ultrasonic-assisted irrigation activation techniques: a randomized clinical trial. Odontology. 2022 Oct;110(4):786-794. doi: 10.1007/s10266-022-00700-0. Epub 2022 Mar 10.

  PMID: 35267110 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 2, 2025
• Study Start: August 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)