Antibacterial Effect and Postoperative Pain After Triton Irrigation Protocol in Necrotic Mandibular Molar

February 21, 2026 updated by: sara hosny mostafa

Evaluation of Antibacterial Effect and Postoperative Pain Following Irrigation Protocol Using Triton in Necrotic Mandibular Molars. A Randomized Clinical Control Trial

This randomized clinical study evaluates the antibacterial effectiveness and postoperative pain following root canal irrigation using the Triton irrigation protocol in necrotic mandibular molars. Thirty-six patients requiring root canal treatment will be included. The study aims to compare bacterial reduction and postoperative pain outcomes after treatment. Results may help improve irrigation protocols and patient comfort during endodontic therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Root canal disinfection is a critical factor affecting the success of endodontic treatment, especially in teeth with necrotic pulps. Irrigation protocols play an essential role in reducing bacterial load inside the root canal system. The Triton irrigation protocol has been introduced to enhance antimicrobial effectiveness and improve debris removal.

This randomized clinical trial will include 36 patients diagnosed with necrotic mandibular molars indicated for root canal treatment. Participants will receive treatment following the assigned irrigation protocol. Bacterial samples will be collected before and after irrigation to evaluate antibacterial effectiveness. Postoperative pain will be assessed using a standardized pain scale during the follow-up period.

The findings of this study are expected to provide clinical evidence regarding the effectiveness of the Triton irrigation protocol in improving disinfection outcomes and reducing postoperative discomfort

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • New Cairo
      • Cairo, New Cairo, Egypt, 11835
        • Faculty of Oral and Dental Medicine , Future University in Egypt
        • Contact:
        • Sub-Investigator:
          • reham hassan, PHD
        • Sub-Investigator:
          • hesham salah, MSc

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-45 years with no sex predilection
  • Medically free Patients with no systemic conditions that can affect post operative pain response.
  • Patients should not be taking any pain medications 24 hours before intervention
  • Positive patients' acceptance for participating in the study
  • Patient able to sign informed consent
  • Permanent mandibular molars diagnosis with pulpal necrosis with asymptomatic apical periodontitis.
  • Mandibular molars without any anatomical variations or severe curvatures with mesial roots configuration weine class 3 and a distal root with 2 distal canals

Exclusion Criteria:

  • Medically compromised patients

    • Patients who have received antibiotic therapy within the last 2 weeks.
    • Pregnant or lactating women.
    • Patients with known allergy to any of the irrigants used.
    • Patients with swelling or acute peri-apical abscess or fistulous tract.
    • Teeth that have:
    • Wide or open apex .
    • Vital pulp tissue .

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: triton group
Participants receive root canal treatment using the Triton irrigation protocol for disinfection of necrotic mandibular molars. The protocol is applied according to the manufacturer's instructions during chemo-mechanical preparation.
Procedure: triton irrigation protocol
Root canal irrigation performed using Triton solution according to a standardized endodontic irrigation protocol during root canal treatment.
Active Comparator: conventional irrigation group
Participants receive root canal treatment using conventional syringe irrigation with sodium hypochlorite during chemo-mechanical preparation.
Procedure: conventional irrigation group
Participants receive conventional root canal irrigation using standard irrigation solutions during chemo-mechanical preparation according to the routine clinical protocol.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
antibacterial effect
Time Frame: immediately after irrigation procedures
Reduction in bacterial count will be evaluated by microbiological sampling before and after irrigation.
immediately after irrigation procedures

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
postoperative pain intensity
Time Frame: 6, 12, 24, and 48 hours after treatment
Postoperative pain will be assessed using a Visual Analog Scale (VAS) following root canal treatment with different irrigation protocols.
6, 12, 24, and 48 hours after treatment

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
sara hosny mostafa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: sara hosny mostafa adly, BDS, Faculty of Oral and Dental Medicine , 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FUE.REC (17)/1-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared to protect participant confidentiality and privacy.

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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