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

NCT ID: NCT07108842

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-06-02

Brief Summary

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

Detailed Description

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Conditions

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Pulpal Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional Needle Irrigation (Control Group)

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.

Group Type ACTIVE_COMPARATOR

Conventional Needle Irrigation

Intervention Type 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.

Conventional Needle Irrigation (Control Group)

Intervention Type 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.

Irrigation Solution

Intervention Type DEVICE

irrigation protocol done with disposable syringe

Irrigation Solution

Intervention Type DEVICE

irrigation protocol done with endoactivator

Sonic Irrigation using EndoActivator (Intervention Group)

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.

Group Type EXPERIMENTAL

endoactivator

Intervention Type DEVICE

in group 2 irrigation done with endoactivator

Irrigation Solution

Intervention Type DEVICE

irrigation protocol done with disposable syringe

Irrigation Solution

Intervention Type DEVICE

irrigation protocol done with endoactivator

Sonic Irrigation with EndoActivator (Experimental Group)

Intervention Type 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.

Interventions

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Conventional Needle Irrigation

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.

Intervention Type PROCEDURE

Conventional Needle Irrigation (Control Group)

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.

Intervention Type DEVICE

endoactivator

in group 2 irrigation done with endoactivator

Intervention Type DEVICE

Irrigation Solution

irrigation protocol done with disposable syringe

Intervention Type DEVICE

Irrigation Solution

irrigation protocol done with endoactivator

Intervention Type DEVICE

Sonic Irrigation with EndoActivator (Experimental Group)

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.

Intervention Type DEVICE

Other Intervention Names

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Sonic Irrigation with EndoActivator (Experimental Group) use of endoactivator

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Non-restorable teeth, teeth with acute or chronic apical abcess, teeth with internal/external root resorption
2. Teeth with anatomical difficulties like open apices, calcified canals, dilacerations
3. Patients that had any serious medical illness or with systemic disorders
4. Previous root canal treatment
5. Periodontally compromised teeth
6. Presence of sinus tract
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HITEC-Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Dr Farhana Altaf

Dr Farhana

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 20647083 (View on PubMed)

Other Identifiers

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Dr Farhana

Identifier Type: -

Identifier Source: org_study_id

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