Comparison of Obturation Quality and Lateral Canal Fill (by Sealer): Ultrasonic-Activated Versus Non-Ultrasonic Conventional Irrigation Techniques in Root Canal Treatment - A Randomized Controlled Trial

The main goal of clinical trail to compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment.

HYPOTHESIS There is a difference in obturation quality and lateral canal fill between ultrasonic activated irrigation results as compared to conventional irrigation technique in root canal treatment.

Eligible patients will be recruited from the Endodontics Department at Peshawar Dental College who present with pain and sensitivity in mandibular teeth and are advised root canal treatment after clinical examination and X-ray. Patients will be screened according to inclusion and exclusion criteria and informed written consent will be taken. This will be a double-blinded study, and demographic and tooth-related information will be recorded.

Participants will be randomized into two groups using block randomization with a block size of six. The Non-Ultrasonic group will receive conventional irrigation using syringe, 3% sodium hypochlorite, and Tg sealer, while the Ultrasonic group will be irrigated using the VAT-3 ultrasonic activator with the same solution and sealer. Pre- and post-operative radiographs will be taken to evaluate obturation quality and lateral canal fill in terms of length, density, and taper using a standardized proforma.

Study Overview

• Status: Not yet recruiting
• Conditions: Comparison Between Two Type of Irrigation Systems
• Intervention / Treatment: Other: ULTRASONIC IRRIGATION TECHNIQUE; Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Syed Shahbaz Ali Shah; Phone Number: 0092 3155119119; Email: shahbazali2288@gmail.com

Study Locations

• Pakistan
  • Khyber Pakhtoon Khawa(KPK)a
    • Peshawar, Khyber Pakhtoon Khawa(KPK)a, Pakistan, 25000
      • Peshawar Dental Collge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Both male and female
• Age group adults 18 to 70 years
• Patients presenting with pain and sensitivity in mandibular molars and advised root canal treatment after examination and x ray

Exclusion Criteria:

• Teeth with complex root canal anatomy that may complicate the obturation process
• Pregnancy
• Medically compromised patients including uncontrolled diabetes -cardiovascular disease immunodeficiency disorders bleeding disorders and -severe respiratory disease
• Patients who refused to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ULTRASONIC IRRIGITATION TECHNIQUE	Other: ULTRASONIC IRRIGATION TECHNIQUE; The utilization of theVAT-3 ultrasonic activator high frequency device (45KHz± 5kHz) [Refine] for the Ultrasonic Activated Irrigation group and same solution of 3% sodium hypochlorite and Tg Sealer will be used. Post-operative radiographs will be obtained to assess the obturation quality and lateral canal fill. A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores.
Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE	Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE; The root canal treatment is then performed as per the assigned group, with conventional irrigation involving the use of syringes and 3% sodium hypochlorite solution and Tg Sealer for the Non-Ultrasonic Conventional Irrigation group.A detailed radiographic proforma will be employed to evaluate the length, density, taper of the root canal filling, and lateral canal fill . Each of these components will be scored individually, and an overall Obturation Quality Score is calculated by summing these scores.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare obturation quality and lateral canal sealer fill between ultrasonic activated and conventional irrigation in root canal treatment	Obturation Quality and Lateral Canal Fill:- This will involve evaluating the length of the root canal filling in the main canals, assessing the homogeneity (density) of the obturation material, determining the taper of the root canal filling, and examining the sealer's penetration into lateral canals using postoperative radiographs. The radiographs will be reviewed independently by two senior endodontists. A scoring system will be applied, and each of the three parameters will be individually assessed. Lateral Canal:- A type of accessory canal located in the coronal or middle third of the root, usually extending horizontally from the main canal space.	Immediate, after completion of procedure

Collaborators and Investigators

• Sponsor: Prime Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 24, 2025

Study Record Updates

• Last Update Posted (Actual): December 24, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: Prime Foundation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 6 months after completion of results.
• IPD Sharing Access Criteria: Researchers studying similar primary outcomes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No