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

NCT07435883 | Not Yet Recruiting

• 1 other identifier: FUE.REC (17)/1-2026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulp Necrosis

Keywords

root canal treatment; endodontics; irrigation protocol; triton irrigation; postoperative pain; antibacterial effect

Outcome Measures

Primary Outcomes (1)

• antibacterial effect

  Reduction in bacterial count will be evaluated by microbiological sampling before and after irrigation.

  immediately after irrigation procedures

Secondary Outcomes (1)

• postoperative pain intensity

  6, 12, 24, and 48 hours after treatment

Study Arms (2)

triton group

EXPERIMENTAL

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

conventional irrigation group

ACTIVE COMPARATOR

Participants receive root canal treatment using conventional syringe irrigation with sodium hypochlorite during chemo-mechanical preparation.

Procedure: conventional irrigation group

Interventions

triton irrigation protocol PROCEDURE

Root canal irrigation performed using Triton solution according to a standardized endodontic irrigation protocol during root canal treatment.

triton group

conventional irrigation group PROCEDURE

Participants receive conventional root canal irrigation using standard irrigation solutions during chemo-mechanical preparation according to the routine clinical protocol.

conventional irrigation group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• sara hosny mostafa: lead

Study Sites (1)

Faculty of Oral and Dental Medicine , Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Necrosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• sara hosny mostafa adly, BDS

  faculty of oral and dental medicine , future university in egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sara hosny mostafa adly, BDS

CONTACT

00201009568678; drsarahosny45@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to group allocation, while the operator delivering the intervention was aware of the assigned treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: postgraduate dentist

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)