Effectiveness of Laser-activated Photoacoustic Flow in One-visit Revision of Teeth With Apical Periodontitis

NCT07387809 | Active Not Recruiting

• 2 other identifiers: 05-PA-2-5/2025School of Dental Medicine
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of the clinical randomized study is to examine the effectiveness laser-activated irrigation (LAI) on the removal of intracanal microorganisms and the healing of an inflammatory periapical lesion of a tooth after a one-visit revision of teeth with apical periodontitis. The main questions are:

1. 1.Does LAI reduces the occurrence of postoperative pain, compared with sonic-activated irrigation?
2. 2.Is antimicrobial efficacy of LAI greater than the antimicrobial efficacy of sonic-activated irrigation?
3. 3.Is periapical lesion healing after LAI application better than after sonic-activated irrigation?

Conditions

Apical Periodontitis

Keywords

apical periodontitis; laser-activated irrigation; single-visit revision

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Following single-visit revision performed with different irrigation activation techniques, occurance, duration and intensity of postoperative pain will be assessed via a questionnaire. A score of 0 represented no pain, while a score of 10 represented the maximum pain, with higher scores indicating greater pain intensity.

  From day 1 after treatment to 7 days postoperatively

• Radiographic healing of periapical lesions

  The healing analysis of the lesion will be performed by volumetric assessment using the ITK-SNAP software. Calculation and volumetric assessment in mm3 will be performed with ITK-SNAP with additional shaping, manual adjustment and transfer. In multi-rooted teeth, the defect will be displayed as the sum of individual periapical processes. All processes smaller than twice the thickness of the periodontal ligament will be counted as 0 mm3, or complete healing.

  At the 12-month

Secondary Outcomes (1)

• Microbiological efficiency

  At the baseline

Study Arms (2)

SSP modality of Er:YAG laser activated irrigation

EXPERIMENTAL

In group 1, irrigant in the final irrigation protocol will be activated by a radial laser attachment (diameter: 400 µm) of an Er:YAG laser (Fotona, Ljubljana, Slovenia). The laser settings will be: SSP mode, pulse energy 20 mJ, frequency 15 Hz, pulse duration 50 µs according to the factory settings of the Er:YAG laser for laser-activated disinfection and according to the endodontic space disinfection protocol (23).

Device: Laser activated irrigation

Sound-activated irrigation (Smart Lite Pro EndoActivator, DentsplySirona)

ACTIVE COMPARATOR

In group 2, each irrigant in the final irrigation protocol will be activated by the polymer tip of the sonic irrigation device. The tip will be placed 2 mm from the working length of the canal. The activation time will be 30 s for NaOCL, 60 s for EDTA and 30 s for NaOCl.

Device: Sound-activated irrigation

Interventions

Laser activated irrigation DEVICE

In this group, the final irrigation protocol will be activated by an Er:YAG laser (Fotona, Ljubljana, Slovenia) in SSP mode.

SSP modality of Er:YAG laser activated irrigation

Sound-activated irrigation DEVICE

In this group, the final irrigation protocol will be activated by the polymer tip of the sonic irrigation device.

Sound-activated irrigation (Smart Lite Pro EndoActivator, DentsplySirona)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• teeth tender to percussion, palpation
• teeth that have a sinus tract and swelling
• a chronic periapical lesion greater than 5 mm in diameter based on the initial X-ray
• previous endodontic treatment and root canal filling that is inadequate according to clinical criteria (filling, overfilling, non-homogeneous root canal filling, unfilled root canals)

You may not qualify if:

• immunocompromised patients
• pregnant women
• teeth with a periodontal pocket depth greater than 3 mm
• teeth with signs and symptoms of vertical fracture
• teeth that cannot be restored or prosthetically provided after endodontic treatment
• use of antibiotic therapy within the last month
• diagnosis of acute apical abscess

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

School of Dental Medicine, University of Zagreb

Zagreb, 10 000, Croatia

Location

Related Publications (20)

• Davies A, Mannocci F, Mitchell P, Andiappan M, Patel S. The detection of periapical pathoses in root filled teeth using single and parallax periapical radiographs versus cone beam computed tomography - a clinical study. Int Endod J.2015;48(6):582-92.

  BACKGROUND

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  BACKGROUND

• Erkan E, Gündoğar M, Uslu G, Özyürek T. Postoperative pain after SWEEPS, PIPS, sonic and ultrasonic-assisted irrigation activation techniques: a randomized clinical trial. Odontology. 2022 Oct;110(4):786-794.

  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.

  BACKGROUND

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• Duncan HF, Kirkevang LL, Peters OA, El-Karim I, Krastl G, Del Fabbro M, Chong BS, Galler KM, Segura-Egea JJ, Kebschull M; ESE Workshop Participants and Methodological Consultant. Treatment of pulpal and apical disease: The European Society of Endodontology (ESE) S3-level clinicalpracticeguideline. Int Endod J. 2023 Oct;56 Suppl 3:238-295.

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• Davies A, Patel S, Foschi F, Andiappan M, Mitchell PJ, Mannocci F. The detection of periapical pathoses using digital periapical radiography and cone beam computed tomography in endodontically retreated teeth - part 2: a 1 year post-treatment follow-up. Int Endod J. 2016;49:623-35;

  BACKGROUND

• Patel S, Wilson R, Dawood A, Mannocci F. The detection of periapical pathosis using periapical radiography and cone beam computed tomography - part 1: preoperative status. Int Endod J. 2012;45:702-10.

  BACKGROUND

• Doğan MU, Arıcıoğlu B, Köse TE, Çıkman AŞ, Öksüzer MÇ. Association between the irrigation-agitation techniques and Periapical Healing of large periapical lesions: a Randomized Controlled Trial. Clin Oral Investig. 2024 Jun 15;28(7):376.

  BACKGROUND

• Martins MR, Carvalho MF, Pina-Vaz I, Capelas JA, Martins MA, Gutknecht N. Outcome of Er,Cr:YSGG laser-assisted treatment of teeth with apical periodontitis: a blind randomized clinical trial. Photomed Laser Surg. 2014 Jan;32(1):3-9.

  BACKGROUND

• Josic U, Mazzitelli C, Maravic T, Fidler A, Breschi L and Mazzoni A. Biofilm in endodontics: in vitro cultivation possibilities, sonic-, ultrasonic- and laser-assisted removal techniques and evaluation of the cleaning efficacy. Polymers (Basel), 2022;14, 1334.

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• Do QL, Gaudin, A. The efficiency of the Er: YAG laser and photoninduced photoacoustic streaming (PIPS) as an activation method in endodontic irrigation: a literature review. JLMS. 2020;11,316-334.

  BACKGROUND

• Jordana J, Tandean JN, Salim JF, Jennifer, Febriastuti C, Sampoerno G. Shock wave enhanced emission photoacoustic streaming (SWEEPS): An alternative to conventional irrigation in endodontic treatment. Conservative Dentistry Journal. 20122. 12:68-72.

  BACKGROUND

• Blanken J, De Moor RJ, Meire M, etal. Laser induced explosive vapor and cavitation resulting in effective irrigation of the root canal. Part 1: a visualization study, LasersSurg Med. 2009;41:7.

  BACKGROUND

• Peters OA, Bardsley S, Fong J, Pandher G, Divito E: Disinfection of root canals with photon-initiated photoacoustic streaming. J.Endod. 2011;1, 37:1008-12.

  BACKGROUND

• Badami V, Akarapu S, Kethineni H, Mittapalli SP, Bala KR, Fatima SR. Efficacy of Laser-Activated Irrigation Versus Ultrasonic-Activated Irrigation: A SystematicReview. Cureus. 2023;15(3): e36352.

  BACKGROUND

• Haapasalo M, Shen Y, Wang Z, Gao Y.Irrigation in endodontics. Braz.Dent. J. 2014;216, 299-303.

  BACKGROUND

• Baumgartner JC, Mader CL. A scanning electronmicroscopic evaluation off our root canal irrigation regimens. J Endod. 1987;13:147-57.

  BACKGROUND

• McComb D, Smith DC. A preliminary scanning electronmicroscopic study of root canals after endodontic procedures. JEndod. 1975;1, 238-42.

  BACKGROUND

• Vertucci FJ. Root canal morphology and its relationship to endodontic procedures. Endod Top. 2005;10(1):3-29.

  BACKGROUND

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Domagoj Kunčić

Study Record Dates

• First Submitted: January 1, 2026
• First Posted: February 4, 2026
• Study Start: January 15, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-01

Locations

CR (1)