Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT.

May 11, 2026 updated by: Mohamed Fawzy Mohamed Sayed Ahmed Omara, Future University in Egypt

Evaluation of the Impact of Different Final Irrigation Activation Modes on Healing of Periapical Lesions Related to Permanent Mandibular First Molars Using CBCT. A Randomized Controlled Trial.

The goal of this clinical trial is to learn how different ways of activating the cleaning liquid (irrigation) during endodontic treatment affect healing of infections at the root tip (periapical lesions) in adults aged 20 to 40 with a lower first molar tooth.

The main question it aims to answer is:

Does the way the cleaning liquid is moved inside the tooth during endodontic treatment change how well the infection at the root tip heals after 12 months?

Researchers will compare four irrigation methods to see which one helps the infection heal best:

A regular needle and syringe (the standard endodontic method) Ultra X, which uses sound waves to push the liquid through the tooth Endo Vac, which uses gentle suction to pull the liquid through the tooth I Vac, which combines suction and sound waves

Participants will:

Have their endodontic treatment done in one visit by the same dentist Be randomly placed into one of the four groups Return for check-ups at 3, 6, and 9 months after endodontic treatment Come back at 12 months for a final check-up and a 3D dental scan (CBCT) to measure how much the infection has healed

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Periapical lesions are areas of infection and inflammation at the tip of a tooth's root. They develop when bacteria from inside the tooth's root canal system spread to the surrounding bone. Endodontic treatment (root canal treatment) aims to remove these bacteria so the infection can heal.

A key part of endodontic treatment is irrigation, which means rinsing the inside of the tooth with cleaning liquids to wash out bacteria, infected tissue, and debris. The two main cleaning liquids used in this study are sodium hypochlorite (NaOCl), which dissolves infected tissue and kills bacteria, and EDTA, which removes the smear layer (a thin film of debris left on the canal walls after cleaning).

The standard way to deliver these liquids is with a needle and syringe. However, the inside of a tooth has complex shapes, narrow areas, and side branches that a needle may not reach. To improve cleaning, dentists can use special devices that activate the liquid, helping it flow into these hard-to-reach areas. Different activation methods work in different ways:

Positive pressure activation uses sound waves to push the liquid deeper into the canals Negative pressure activation uses gentle suction to pull the liquid through the canals toward the root tip, which also helps stop the liquid from being pushed out beyond the root Combined activation uses both suction and sound waves at the same time

It is not yet clear which activation method leads to the best healing of periapical lesions over time. This study will compare four irrigation methods in adults to find out.

Study Design

This is a randomized controlled clinical trial. A total of 52 adults aged 20 to 40 years will take part. Participants will be randomly placed into one of four equal groups (13 people per group):

Group A (control group): Conventional needle irrigation. The cleaning liquid is delivered with a regular side-vented needle placed 2 mm short of the root tip.

Group B: Ultra X activation. A device that uses sound waves to activate the liquid.

Group C: Endo Vac activation. A device that uses suction to pull the liquid through the canals.

Group D: I Vac activation. A device that combines suction and sound waves.

Who Can Take Part

People may join the study if they:

Are between 20 and 40 years old Are in good general health Have a lower first molar that can be restored, with signs of symptomatic apical periodontitis and a small to moderate periapical lesion seen on a CBCT scan Agree to take part and sign a consent form

People cannot join the study if they:

Have a serious medical condition Are pregnant or breastfeeding Have an allergy to any medication used in the study Have a tooth that is loose, cannot be restored, has unusual anatomy, or has already had a root canal

What Participants Will Do

All endodontic treatment will be done in one visit by the same dentist. The steps are:

A full medical and dental history will be taken Before treatment, X-rays and a 3D dental scan (CBCT) will be taken to measure the size of the infection. This scan is the baseline for comparing how much healing happens later The tooth area will be numbed with local anesthesia Any decay will be removed and the tooth will be opened to reach the canals A rubber dam will be placed around the tooth to keep it clean and dry The length of each canal will be measured using an electronic device and confirmed with an X-ray The canals will be shaped and cleaned using rotary files, with 2.5% sodium hypochlorite used between each file The final rinse will be done using the method assigned to the participant's group, with 17% EDTA followed by 2.5% sodium hypochlorite. Saline will be used between liquids to prevent them from mixing The canals will be dried and filled using gutta-percha and a resin-based sealer The tooth will be restored with a resin composite filling

Follow-Up Participants will return for follow-up visits at 3, 6, 9, and 12 months. At each visit, the dentist will check the tooth and take a regular X-ray. At the 12-month visit, a new CBCT scan will be taken to measure how much the infection has healed.

How Healing Is Measured

The main outcome is healing of the periapical lesion at 12 months, measured using the Cone Beam Computed Tomography Periapical Index (CBCT-PAI). At 12 months, each tooth will be placed into one of three groups:

Healed: No symptoms and a CBCT-PAI score of 1 or 2, or no sign of infection on the scan Healing: No symptoms and a smaller lesion on the scan Diseased: Symptoms are present, or the lesion is the same size or larger

Teeth that are healed or healing will be counted as successful treatment. Teeth that are diseased will be counted as unsuccessful.

Risks and Confidentiality Any side effects will be recorded. All participant information will be kept private and stored securely. Data will be password-protected and kept for one year after the study ends.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • New Cairo
      • Cairo, New Cairo, Egypt, 118535
        • Future university in Eygpt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).
  • The age range is between 20 to 40 years.
  • Patients have restorable Mandibular permanent molars that were diagnosed with necrotic pulp with symptomatic apical periodontitis (with small to moderate periapical lesion/≤ 5mm) .
  • Positive patient's acceptance for participating in the study.
  • Patients able to sign informed consent.
  • Both male and female patients are eligible.
  • Good oral hygiene.
  • Mandibular first molars with two roots (mesial and distal), each presenting a Weine Type III canal configuration.

Exclusion Criteria:

  • - Medically compromised patients.
  • Pregnant or lactating females.
  • Psychologically disturbed patients.
  • Patients with a history of allergy to any medication used in the study were excluded.

  • Mandibular first molar with:

    • Wide or open apex.
    • Vital pulp tissues.
    • Periodontally affected with grade 2 or 3 mobility.
    • Not restorable teeth.
    • Abnormal anatomy and calcified canals.
    • Previous root canal treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: side vented needle
single visit root canal treatment with final irrigation protocol using side vented needle
Procedure: root canal treatment
single visit root canal treatment with final irrigation protocol according to arm
Active Comparator: passive ultrasonic irrigation activation (Ultra X )
single visit root canal treatment with final irrigation protocol using ultrasonic ( Ultra X )
Procedure: root canal treatment
single visit root canal treatment with final irrigation protocol according to arm
Active Comparator: apical negative pressure irrigation activation ( Endo Vac)
single visit root canal treatment with final irrigation protocol using apical negative pressure irrigation activation( Endo Vac )
Procedure: root canal treatment
single visit root canal treatment with final irrigation protocol according to arm
Active Comparator: Apical Negative Pressure Irrigation and Activation System (iVac)
single visit root canal treatment with final irrigation protocol using Apical Negative Pressure Irrigation and Activation System (iVac)
Procedure: root canal treatment
single visit root canal treatment with final irrigation protocol according to arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing of periapical lesion
Time Frame: 12 month
percent reduction lesion size after root canal treatment using CBCT-PAI scores
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2025

Primary Completion (Actual)

May 3, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC (45)/11-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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