Quantitative Assessment of the Efficacy of Two Irrigation Activation Systems

NCT05690763 | Completed

• 1 other identifier: Microbial analysis
• 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 \[ XP-endo Finisher and EndoActivator \] 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. 20 patients with posttreatment apical periodontitis (one tooth each) were randomly allocated into two groups according to the used (n=10, for each): the EA group (A) or the XPF 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; Irrigation Activation

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Study Arms (2)

XP-endo Finisher

EXPERIMENTAL

use of XP-endo Finisher

Other: XP-endo Finisher to use irrigation activation

EndoActivator

EXPERIMENTAL

use of EndoActivator

Other: EndoActivator to use irrigation activation

Interventions

XP-endo Finisher to use irrigation activation OTHER

XPF : The canals were flushed with 2.5 mL 2.5% NaOCl for 30 s and activated by a XPF instrument that was placed in the canal to 1 mm short of the WL and powered by the motor at 800 rpm (1 N-cm torque) for 30 s according to the manufacturer's instructions. Then the canals were rinsed with 2.5 mL of 2.5% NaOCl, followed by activation of the substance with the XPF instrument for 30 seconds, the same way as above. A new XP-endo Finisher file was used for each canal.

XP-endo Finisher

EndoActivator to use irrigation activation OTHER

The root canals were irrigated with 2.5 mL of 2.5% NaOCl for 30 s, followed by sonic activation of this solution with EndoActivator red tip size #25/0.04, inserted into the root canal 1 mm short of the WL, at 10,000 cpm/min. for 30 seconds. The EA polymer tip moved vertically from apical to coronal part of the canal during activation.

EndoActivator

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 post-treatment apical periodontitis had endodontic therapy completed more than 2 years earlier and required retreatment.
• Radiographically, the diameter of the periapical radiolucency ranged from 2 to 7 mm.
• Termini of the root canal fillings ranged from 0-4 mm short of the radiographic apex, with no overfilling.
• 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: December 16, 2022
• First Posted: January 19, 2023
• Study Start: February 7, 2022
• Primary Completion: September 2, 2022
• Study Completion: December 2, 2022
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

TU (1)