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

NCT07303478 | Not Yet Recruiting DMC

• 1 other identifier: Prime Foundation
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Comparison Between Two Type of Irrigation Systems

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ULTRASONIC IRRIGITATION TECHNIQUE

OTHER

Other: ULTRASONIC IRRIGATION TECHNIQUE

NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE

OTHER

Other: NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE

Interventions

ULTRASONIC IRRIGATION TECHNIQUE OTHER

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.

ULTRASONIC IRRIGITATION TECHNIQUE

NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE OTHER

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.

NON-ULTRASONIC CONVENTIONAL IRRIGATION TECHNIQUE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prime Foundation: lead

Study Sites (1)

Peshawar Dental Collge

Peshawar, Khyber Pakhtoon Khawa(KPK)a, 25000, Pakistan

Location

Central Study Contacts

Dr. Syed Shahbaz Ali Shah

CONTACT

0092 3155119119; shahbazali2288@gmail.com

Study Design

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

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 6 months after completion of results.
• Access Criteria: Researchers studying similar primary outcomes

Locations

PA (1)