Effect of Different Irrigation Activating Techniques on Irrigant Penetration Depth and on Post-Operative Pain

NCT05450003 | Completed FDA Device

• 1 other identifier: Elgazzar YF1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Irrigation activation in endodontics is considered now a very important step for the success of root canal treatment. In this study, the investigator will examine the effect of two recent activation systems ( XP-endo Finisher file and the new sonic EDDY system) in comparison with the conventional needle irrigation on irrigant penetration depth into root canals using radiopaque contrast media and digital radiography and on the postoperative pain after single-visit endodontic treatment using a visual analog scale.

Conditions

Irrigation Activation

Outcome Measures

Primary Outcomes (2)

• irrigant penetration depth

  measurement of irrigant penetration depth using radioaque media and digital radiography

  through study completion, an average of 3 months

• postoperative pain

  evaluation of postoperative pain using visual analog scale VAS with scores from 0 to 100. score 0 indicated no pain while score 100 indicates maximum pain

  through study completion, an average of 3 months

Study Arms (3)

xp endo finisher file

OTHER

Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation

new sonic EDDY system

OTHER

Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation

syringe needle irrigation

OTHER

Device: Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation

Interventions

Irrigation activation using xp endo finisher file , new sonic eddy tip and conventional needle syringe irrigation DEVICE

irrigation activation using 3 different irrigation activation systems including xp endo finisher file , new sonic eddy system and conventional needle syringe irrigation

new sonic EDDY system; syringe needle irrigation; xp endo finisher file

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic vital/non vital teeth requiring root canal treatment.
• Teeth with sound periodontal apparatus.
• Teeth without pus or inflammatory exudates draining through the canal.
• Teeth without anatomic variations.
• Teeth with sinus tract.
• Teeth without history of trauma.
• Patients not on analgesics or sedative medication prior to root canal therapy

You may not qualify if:

• Patients with any systemic diseases.
• Pregnant or lactating patients.
• Immunocompromised patients.
• Apparently thin roots in which apical preparation with #40 file would be overzealous.
• Patient allergic to anything used in this procedure especially rubber dam material and Iohexol (radiographic contrast media).
• Teeth with calcified canals.
• Patients with acute apical periodontitis, acute apical abscess, and weeping canals.
• Necrotic painful teeth with the absence of sinus tract for drainage.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Dentistry, Tanta University

Tanta, Egypt

Location

Related Publications (1)

• Elgazzar YFK, Darrag AM, Attia DAM. Effect of XP-endo Finisher and EDDY activation on post-operative pain after single-visit endodontic treatment: a randomized controlled clinical trial. Sci Rep. 2025 Nov 4;15(1):38476. doi: 10.1038/s41598-025-23628-1.

  PMID: 41188367 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Administrator of endodontics faculty of dentistry Tanta university

Model Details: the study will evaluate 3 groups of patients each consists of 10 participants receiving different type of irrigation activation.

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: July 8, 2022
• Study Start: August 1, 2022
• Primary Completion: November 12, 2022
• Study Completion: November 25, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

EG (1)