The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain

NCT06501703 | Completed

• 1 other identifier: 2024/832
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The trial was conducted to assess the impact of passive ultrasonic irrigation, XP endo finisher, AF max file, and manual dynamic agitation on postoperative pain and analgesic consumption at 6 h., 12 h., 24 h., 48 h., 72 h., and a week later on single-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis.

Conditions

Acute Pulpitis With Apical Periodontitis, Postoperative Pain

Keywords

Fanta AF max file, Passive ultrasonic irrigation, Postoperative pain, XP-endo Finisher.

Outcome Measures

Primary Outcomes (1)

• The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain

  Patients will be informed about the possible development of pain. Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment. The VRS consisted of a four-step pain scale using a continuous 0-3 point scale; No pain (0): the treated tooth felt normal. Patients did not have any pain or discomfort, mild (1): recognizable, not discomforting), moderate (2): discomforting, but bearable, and severe (3): considerable discomfort, difficult to bear. Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake.

  6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.

Study Arms (4)

XP Endo finisher

EXPERIMENTAL

technique used for final irrigation in vertical lengthwise movement to the full working length for 1 minute in each canal.

Other: Instruments

Passive Ultrasonic Irrigation

EXPERIMENTAL

technique used for final irrigation in vertical strokes reaching 2 mm short from the full working length for 1 minute in each canal.

Other: Instruments

Fanta AF max file

EXPERIMENTAL

technique used for final irrigation in vertical lengthwise movement to the full working length for 1 minute in each canal.

Other: Instruments

Manual Dynamic agitation

ACTIVE COMPARATOR

technique used for final irrigation in Intermittent manual activation for 1 min in up-and-down motion using master gutta percha cone was performed.

Other: Instruments

Interventions

Instruments OTHER

instruments used as different techniques in final irrigation after root canal preparation

Also known as: XP Endo finisher, Passive Ultrasonic Irrigation, Fanta AF max file, Manual dynamic agitation

Fanta AF max file; Manual Dynamic agitation; Passive Ultrasonic Irrigation; XP Endo finisher

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• solitary-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis who were in the age range between 18 and 40 years old.
• Each patient received root canal treatment in one session.
• restorable teeth with a normal periodontal score index of less than two
• severe preoperative pain (Vas score 3)
• discomfort response on biting/mastication or percussion but no mobility.
• Discomfort response on palpation of surrounding tissue but with no intraoral swelling.
• Patients who stopped medications for the last 12 hours before the procedure
• The radiograph showed only normal or slight widening in the periodontal ligament space of the affected root.

You may not qualify if:

• patients with any serious systemic disease
• Patients under the age of eighteen or incapable of giving informed consent
• Patients over forty
• Patients with a mandibular premolar involving multiple canals or huge periapical pathosis
• Patients with severe preoperative pain on biting/mastication or percussion
• Mandibular premolar with open apices
• Mandibular premolar with periodontal involvement
• Retreated cases, sinus tract presence, and swelling of surrounding soft tissues
• patients who had been pregnant and allergic patients with local anesthetic agents

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Sinai University

Ismailia, 1141, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yasmin T sobh, PHD

  faculty of Dentistry , sinai university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double (participants ,outcome assessors)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontic lecturer

Model Details: Parallel double blinded

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: June 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)