NCT07731594

Brief Summary

This study aims to compare the effectiveness of three root canal irrigation techniques-Conventional Needle Irrigation (CNI), Side-Vented Needle (SVN), and Ultrasonic Irrigation (UI)-in achieving irrigant penetration into the apical third of the root canal. Since conventional irrigation often fails to adequately clean complex root canal anatomy, the study evaluates whether activation methods improve irrigant penetration. A randomized controlled trial will compare these three techniques using extracted single-rooted mandibular premolars. A radiopaque dye mixed with sodium hypochlorite will be used to measure irrigant penetration on digital radiographs, and the results will be statistically analyzed to determine the most effective irrigation method.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Jul 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 12, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 22, 2026

Last Update Submit

July 25, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Depth of irrigant penetration into the apical third of the root canal (measured in millimeters).

    The primary outcome is the depth of penetration of a radiopaque irrigant solution into the apical third of the root canal following irrigation with Conventional Needle Irrigation (CNI), Side-Vented Needle Irrigation (SVN), or Ultrasonic Irrigation (UI). Penetration depth will be measured on digital radiographs as the distance from the apical foramen to the deepest point reached by the irrigant.

    5 months

Study Arms (3)

Conventional Needle Irrigation

ACTIVE COMPARATOR

Participants in this group will receive root canal irrigation using a conventional 27-gauge syringe needle. The irrigant, consisting of a radiopaque iohexol dye mixed with 5.25% sodium hypochlorite, will be delivered into the prepared root canal using the conventional needle irrigation technique. Irrigant penetration into the apical third will be assessed using digital radiographs.

Procedure: Conventional Needle

Side Vented Needle Irrigation

ACTIVE COMPARATOR

Participants in this group will receive root canal irrigation using a side-vented irrigation needle. The radiopaque irrigant solution, prepared by mixing iohexol dye with 5.25% sodium hypochlorite, will be delivered into the canal using the side-vented needle technique. Irrigant penetration into the apical third will be measured on digital radiographs.

Procedure: Side Vented Needle

Ultrasonic Irrigation

EXPERIMENTAL

Participants in this group will receive ultrasonic irrigation following completion of canal preparation. A radiopaque irrigant solution consisting of iohexol dye mixed with 5.25% sodium hypochlorite will be ultrasonically activated within the root canal. Digital radiographs will be used to measure the depth of irrigant penetration into the apical third and compare it with the other irrigation techniques

Procedure: Ultrasonic Irrigation

Interventions

Conventional syringe irrigation will be performed using a 27-gauge needle to deliver the radiopaque sodium hypochlorite solution into the prepared root canal. No additional activation technique will be used during irrigation

Conventional Needle Irrigation

Irrigation will be carried out using a side-vented needle to introduce the radiopaque sodium hypochlorite solution into the prepared canal. The side-vented design is intended to improve irrigant distribution within the canal while minimizing direct apical flow

Side Vented Needle Irrigation

Following canal preparation, the radiopaque sodium hypochlorite solution will be activated using an ultrasonic device to enhance irrigant movement throughout the root canal system before radiographic evaluation of penetration depth.

Ultrasonic Irrigation

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Straight Canals
  • Single Rooted 1st and 2nd mandibular premolars with closed apices

You may not qualify if:

  • Mandibular premolars with open apices
  • Mandibular premolars with curved or calcified canals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Haroon H Panezai, BDS

    School Of Dentistry, Shaheed Zulfiqar Ali Bhutto Medical University, Islamabad

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Haroon H Panezai, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2026

First Posted

July 28, 2026

Study Start

July 12, 2026

Primary Completion (Estimated)

November 10, 2026

Study Completion (Estimated)

December 26, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share