Quantitative Assessment of the Efficacy of Sweeps Laser Activation Systems

NCT05718596 | Completed

• 1 other identifier: Microbial analysis root canal
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the present study was to determine the intraradicular microbiota of previously root canal-treated teeth with apical periodontitis using droplet digital polymerase chain reaction (ddPCR) and to investigate the antibacterial effectiveness of different irrigation activation methods \[ Sweeps laser and PUI group \] that will make classical chemomechanical preparation more effective. This superiority, parallel, randomized clinical trial was conducted in the clinic of the Endodontic Department, Faculty of Dentistry, Istanbul Medipol University, Istanbul. 30 patients with apical periodontitis (one tooth each) were randomly allocated into two groups according to the used (n=15, for each): the Sweeps laser group (A) or the vdw ultra group (B). Total bacterial loads, as well as the amount of Enterococcus faecalis (E.faecalis) were determined before (S1) and after (S2) chemomechanical preparation and finally, after intracanal medication (S3) by means of ddPCR.

Conditions

Periapical Periodontitis; Polymerase Chain Reaction; Enterococcus Faecalis Infection

Outcome Measures

Primary Outcomes (1)

• the sequence analysis of 16S rRNA genes by the Sanger sequencing

  hrough study completion, an average of 1 year

Study Arms (2)

Sweeps laser

EXPERIMENTAL

use of sweeps laser irrigation activation

Other: sweeps laser to use irrigation activation

pasif ultrasonic irrigation (PUI)

EXPERIMENTAL

Pasif ultrasonic irrigation (PUI) -VDW Ultra

Other: PUI to use irrigation activation

Interventions

sweeps laser to use irrigation activation OTHER

The SWEEPS fiber tip (25 µs ultra-short dual pulse mode-Auto SWEEPS mode) was inserted into the Er:YAG laser source (2,940 nm, 20 mJ per pulse, 15 Hz, 0.3 W power, and 50 µs pulse frequency). 3% NaOCl solution was activated in three periods of 20 s. Then, the same procedure was repeated with 2 ml of 17% EDTA solution.

Sweeps laser

PUI to use irrigation activation OTHER

The irrigation solution was used by adapting an ultrasonic tip (IRRI S 21/25; VDW, Munich, Germany) to an ultrasonic device (VDW Ultra; VDW, Munich, Germany). The tip was activated a total of three times, with each cycle lasting 20 s and involving the use of 1 ml of 3% NaOCl. Then, 2 ml of 17% EDTA solution was activated for 1 min as describe above. The ultrasonic tip was placed 2 mm behind the working length without touching the canal walls.

pasif ultrasonic irrigation (PUI)

Eligibility Criteria

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

You may qualify if:

• root canal-treated teeth exhibiting clinical and radiographic evidence of chronic apical periodontitis lesions.
• Teeth with lesion apical periodontitis
• Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
• The teeth had intact coronal restorations, with no obvious exposure of the root-filling material to the oral cavity.
• Selected teeth had enough crown structure for adequate isolation with a rubber dam and showed an absence of periodontal pockets or attachment level deeper than 4 mm.

You may not qualify if:

• teeth from patients who had received antibiotics within the previous 3 months or who had any general disease, teeth that could not be properly isolated with rubber dam, teeth with absence of coronary sealing, teeth with periodontal pocket depth \>4 mm; and teeth with crown/root fracture. Only one tooth was included from each patient.

Sponsors & Collaborators

• Seyda Ersahan, DDS, PhD: lead

Study Sites (1)

Istanbul Medipol University, Faculty of Dentistry

Istanbul, Esenler, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

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

Study Officials

• SEYDA ERSAHAN, Assoc.Prof.

  IstanbulMedipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The Antimicrobial Efficacy of Sweeps Laser Compared to Ultrasonically Activated Irrigation and Needle Irrigation in Posterior Teeth With Apical Periodontitis: A Clinical Study

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 8, 2023
• Study Start: September 10, 2022
• Primary Completion: November 10, 2022
• Study Completion: December 10, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

TU (1)