Assessment of Pain Using Two Different Irrigation Systems After Root Canal Treatment

NCT07108842 | Completed DMC

• 1 other identifier: Dr Farhana
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

assessment of pain using two different irrigation systems after root canal treatment

Conditions

Pulpal Inflammation

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain

  Assessment of postoperative pain intensity using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst possible pain).

  Pain scores will be recorded at 6 hours, 24 hours, and 48 hours after completion of root canal treatment.

Secondary Outcomes (1)

• Analgesic Consumption

  0 to 48 hours after treatment

Study Arms (2)

Conventional Needle Irrigation (Control Group)

ACTIVE COMPARATOR

Patients in this group will receive traditional syringe and needle irrigation during root canal treatment. An open ended irrigation needle will be used to deliver 2.5% sodium hypochlorite into the root canal system. The needle will be placed 1-2 mm short of the working length, and irrigation will be performed intermittently during canal instrumentation. No additional activation method will be used.

Procedure: Conventional Needle Irrigation; Device: Conventional Needle Irrigation (Control Group); Device: Irrigation Solution

Sonic Irrigation using EndoActivator (Intervention Group)

EXPERIMENTAL

Patients in this group will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using the EndoActivator with a medium-sized (25/04) polymer tip. The device will operate at sonic frequencies (\~6000 cycles/min) for 30 seconds per canal to enhance irrigant penetration and cleaning efficacy, particularly in the apical third and lateral canals.

Device: endoactivator; Device: Irrigation Solution; Device: Sonic Irrigation with EndoActivator (Experimental Group)

Interventions

Conventional Needle Irrigation PROCEDURE

Patients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used.

Also known as: Sonic Irrigation with EndoActivator (Experimental Group)

Conventional Needle Irrigation (Control Group)

Conventional Needle Irrigation (Control Group) DEVICE

Patients in this arm will receive traditional syringe and needle irrigation using a 30-gauge side-vented needle. 2.5% sodium hypochlorite will be used as the irrigant, delivered 1-2 mm short of working length intermittently during root canal instrumentation. No activation device will be used.

Also known as: use of endoactivator

Conventional Needle Irrigation (Control Group)

endoactivator DEVICE

in group 2 irrigation done with endoactivator

Sonic Irrigation using EndoActivator (Intervention Group)

Irrigation Solution DEVICE

irrigation protocol done with disposable syringe

Conventional Needle Irrigation (Control Group); Sonic Irrigation using EndoActivator (Intervention Group)

Sonic Irrigation with EndoActivator (Experimental Group) DEVICE

Patients in this arm will receive sonic activation of the irrigant using the EndoActivator device during root canal treatment. After initial instrumentation and irrigation with 2.5% sodium hypochlorite, the irrigant will be activated using a medium-sized (25/04) EndoActivator tip for 30 seconds per canal at a sonic frequency (\~6000 cycles/min), to enhance cleaning and irrigant penetration.

Sonic Irrigation using EndoActivator (Intervention Group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Single rooted teeth (Anterior or posterior)
• Teeth with symptomatic irreversible pulpitis with acute apical periodontitis
• Age group 18-65 years

You may not qualify if:

• Non-restorable teeth, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
• Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
• Patients that had any serious medical illness or with systemic disorders
• Previous root canal treatment
• Periodontally compromised teeth
• Presence of sinus tract

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

• Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

  PMID: 20647083 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Farhana

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: June 3, 2024
• Primary Completion: June 2, 2025
• Study Completion: June 2, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)