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

Not yet recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

36

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 Contact

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

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
Intervention / Treatment
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

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

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

sara hosny mostafa

Investigators

  • 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)

March 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

February 21, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 21, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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