Laser-Activated Versus Passive Ultrasonic Irrigation in Endodontic Retreatment
Comparison of the Efficacy of PIPS and SWEEPS Laser-activated Irrigation Versus Passive Ultrasonic Irrigation in Reducing Viable Intracanal Bacteria During Endodontic Retreatment of Teeth With Apical Periodontitis: a Culture-based Randomized Controlled Trial
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Brief Summary
This study will compare three methods of activating the final irrigation solution in reducing living bacteria inside the root canals of teeth that require root canal retreatment because of apical periodontitis, an inflammatory condition of the tissues around the root tip. The three methods are photon-induced photoacoustic streaming (PIPS), shock wave-enhanced emission photoacoustic streaming (SWEEPS), and passive ultrasonic irrigation (PUI). Ninety adults requiring retreatment of a single-rooted, single-canal tooth will be randomly assigned to three groups; all treatment steps other than the activation method will be identical. Root canal samples will be collected at several stages of the single-visit treatment, and living bacteria will be counted using laboratory cultures. In addition, real-time PCR will be used to measure the relative amount of Enterococcus faecalis DNA compared with total bacterial DNA. Because PCR cannot distinguish living from dead bacteria, these molecular results will be interpreted as complementary to the culture findings.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
not yet recruiting
Estimated enrollment
90 participants
Study completion date
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
October 22, 2026
Actual (reported)
First Posted
October 29, 2026
Actual (reported)
Study Start
November 2026
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Reduction in Viable Total Cultivable Intracanal Bacterial Load From S2 to S3
Viable total cultivable intracanal bacteria will be quantified by culture as colony-forming units per milliliter (CFU/mL). For each participant, the reduction will be calculated as log10 CFU/mL at S2 minus log10 CFU/mL at S3 and reported in log10 CFU/mL. The reduction will be compared among the PIPS, SWEEPS and passive ultrasonic irrigation groups. S1 denotes sampling after removal of the root canal filling material and before chemomechanical preparation; S2, after chemomechanical preparation and before final irrigant activation; S3, immediately after final irrigant activation.
Day 1 (During the single treatment visit, from completion of chemomechanical preparation (S2) to immediately after final irrigant activation (S3).)
Secondary Outcomes (6)
Reduction in Viable Total Cultivable Intracanal Bacterial Load From S1 to S2
Day 1 (During the single treatment visit, from root canal filling removal (S1) to completion of chemomechanical preparation (S2).)
Overall Reduction in Viable Total Cultivable Intracanal Bacterial Load From S1 to S3
Day 1 (During the single treatment visit, from root canal filling removal (S1) to immediately after final irrigant activation (S3).)
Reduction in Viable Intracanal Enterococcus faecalis Load From S1 to S2
Day 1 (During the single treatment visit, from root canal filling removal (S1) to completion of chemomechanical preparation (S2).)
Reduction in Viable Intracanal Enterococcus faecalis Load From S2 to S3
Day 1 (During the single treatment visit, from completion of chemomechanical preparation (S2) to immediately after final irrigant activation (S3).)
Overall Reduction in Viable Intracanal Enterococcus faecalis Load From S1 to S3
Day 1 (During the single treatment visit, from root canal filling removal (S1) to immediately after final irrigant activation (S3).)
Study Arms (3)
PIPS Laser-Activated Irrigation
EXPERIMENTAL
Thirty participants will undergo standardized single-visit nonsurgical root canal retreatment. Following chemomechanical preparation, the final 5% NaOCl irrigant will be activated using photon-induced photoacoustic streaming (PIPS) with an Er:YAG laser (2940 nm; LightWalker ST-E Pro, Fotona d.o.o., Ljubljana, Slovenia).
Device: Photon-Induced Photoacoustic Streaming
SWEEPS Laser-Activated Irrigation
EXPERIMENTAL
Thirty participants will undergo standardized single-visit nonsurgical root canal retreatment. Following chemomechanical preparation, the final 5% NaOCl irrigant will be activated using shock wave-enhanced emission photoacoustic streaming (SWEEPS) with an Er:YAG laser (2940 nm; LightWalker ST-E Pro, Fotona d.o.o., Ljubljana, Slovenia).
After S2 sampling, 3 mL of 17% EDTA will be delivered with the needle 2 mm short of the working length and left for 3 minutes without activation, then aspirated, and the canal will be rinsed with 5 mL of sterile saline. The canal and pulp chamber will be filled with 2 mL of 5% NaOCl and activated for 20 seconds with an Er:YAG laser (2940 nm; LightWalker ST-E Pro, Fotona d.o.o., Ljubljana, Slovenia) in PIPS mode at 20 mJ, 15 Hz, 0.3 W and 50-microsecond pulse duration, with water and air spray off. A tapered PIPS 600/9 tip (600 micrometers, 9 mm) will be held stationary in the access cavity above the canal orifice without insertion into the canal. This will be repeated three times with fresh 2 mL of NaOCl (total 6 mL, 60 seconds of activation), keeping the pulp chamber filled throughout.
Meire M, De Moor RJG. Principle and antimicrobial efficacy of laser-activated irrigation: A narrative review. Int Endod J. 2024 Jul;57(7):841-860. doi: 10.1111/iej.14042. Epub 2024 Feb 10.
Siqueira JF Jr, Rocas IN. A critical analysis of research methods and experimental models to study the root canal microbiome. Int Endod J. 2022 Mar;55 Suppl 1:46-71. doi: 10.1111/iej.13656. Epub 2021 Nov 16.
Barbosa-Ribeiro M, Arruda-Vasconcelos R, Mendes Louzada L, Rodrigues Lima A, Marciano M, Affonso de Almeida JF, De-Jesus-Soares A, Zaia AA, Ferraz C, Gomes BP. Microbiological Investigation in Teeth with Persistent/Secondary Endodontic Infection in Different Stages of Root Canal Retreatment. Eur Endod J. 2020 Dec;5(3):219-225. doi: 10.14744/eej.2020.73626.
Laboratory personnel performing the microbiological analyses and the statistician will be blinded to group allocation. Samples and datasets will be identified using coded group labels. The clinician performing the interventions will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a single-center, three-arm, parallel-group randomized controlled clinical trial. Ninety participants will be assigned in a 1:1:1 ratio to PIPS, SWEEPS, or passive ultrasonic irrigation using block randomization, with 30 participants per group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor
Study Record Dates
First Submitted
October 22, 2026
First Posted
October 29, 2026
Study Start
NCT07249450
Comparison of Sonic and Ultrasonic Activation on Healing of Apical Periodontitis
Thirty participants will undergo standardized single-visit nonsurgical root canal retreatment. Following chemomechanical preparation, the final 5% NaOCl irrigant will be activated using passive ultrasonic irrigation (PUI) with an ultrasonic device (Woodpecker DTE S6, Guilin Woodpecker Medical Instrument Co., Ltd., Guilin, China).
Device: Passive Ultrasonic Irrigation
Device
After S2 sampling, 3 mL of 17% EDTA will be delivered with the needle 2 mm short of the working length and left for 3 minutes without activation, then aspirated, and the canal will be rinsed with 5 mL of sterile saline. The canal and pulp chamber will be filled with 2 mL of 5% NaOCl and activated for 20 seconds with an Er:YAG laser (2940 nm; LightWalker ST-E Pro, Fotona d.o.o., Ljubljana, Slovenia) in AutoSWEEPS mode at 20 mJ, 15 Hz and 0.3 W, with water and air spray off. A Radial SWEEPS 600/9 tip (600 micrometers, 9 mm) will be held stationary in the access cavity above the canal orifice without insertion into the canal. This will be repeated three times with fresh 2 mL of NaOCl (total 6 mL, 60 seconds of activation), keeping the pulp chamber filled throughout.
After S2 sampling, 3 mL of 17% EDTA will be delivered with the needle 2 mm short of the working length and left for 3 minutes without activation, then aspirated, and the canal will be rinsed with 5 mL of sterile saline. The canal and pulp chamber will be filled with 2 mL of 5% NaOCl and activated for 20 seconds with a Woodpecker DTE S6 ultrasonic device (Guilin Woodpecker Medical Instrument Co., Ltd., Guilin, China) and an ED60 tip in Endo mode at power level 2. The tip will be positioned 2 mm short of the working length and activated without contacting the root canal walls. This will be repeated three times with fresh 2 mL of NaOCl (total 6 mL, 60 seconds of activation), keeping the pulp chamber filled throughout.
Also known as: PUI
Passive Ultrasonic Irrigation
Persistent or secondary apical periodontitis with a Periapical Index (PAI) score of at least 3.
Root canal filling material considered completely removable by nonsurgical means.
Sufficient coronal tooth structure to allow rubber dam isolation.
Only one tooth per participant will be included.
You may not qualify if:
Antibiotic use within the preceding 3 months.
Pregnancy or breastfeeding.
American Society of Anesthesiologists physical status classification II or higher.
Periodontal probing depth greater than 4 mm in the study tooth.
Root fracture, perforation, or root resorption in the study tooth.
A calcified or non-negotiable root canal.
Acute abscess or active drainage.
A non-removable post or a separated instrument in the root canal.
Hepsenoglu YE, Ersahan S, Erkan E, Gundogar M, Ozcelik F. Is SWEEPS better than PUI in reducing intracanal bacteria and inflammation in cases of apical periodontitis? Lasers Med Sci. 2024 Jul 16;39(1):182. doi: 10.1007/s10103-024-04117-9.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 2027
Estimated
Planned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
Data Sharing
IPD Sharing
Will not share
Individual participant data will not be made publicly available because participants' informed consent and the ethics committee approval do not cover data sharing with third parties. Aggregated results will be reported in the publication. De-identified data may be made available by the corresponding author upon reasonable request, subject to approval by the institutional ethics committee.
Source record
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Source: ClinicalTrials.gov.
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