Measure Postoperative Pain and Bacterial Reduction After Different Final Irrigation Protocols.

NCT07191990 | Active Not Recruiting

• 1 other identifier: SamarRCT01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of root canal treatment is to clean, disinfect, and hermetically seal the root canal system to prevent bacterial penetration; however, postoperative pain is frequently encountered, particularly in patients with symptomatic irreversible pulpitis. This condition, defined by the American Association of Endodontists as an irreversible inflammatory state of the pulp, is commonly associated with spontaneous pain, lingering discomfort, and heightened thermal sensitivity, and often represents a significant challenge in endodontics. Postoperative pain is usually linked to extrusion of microorganisms and debris into the periapical region during chemo-mechanical preparation. Bacteria remain the most persistent pathogens in root canal infections, and although sodium hypochlorite (NaOCl) is considered the most effective irrigant due to its antibacterial and tissue-dissolving properties, complete bacterial elimination before root filling is not always achieved. To enhance its antimicrobial efficacy, various adjunctive approaches have been suggested, including passive ultrasonic activation (PUA) and modifying NaOCl temperature, either by heating or cooling. Cryotherapy has gained increasing attention in endodontics for its potential to decrease postoperative pain and bacterial load, with additional reported benefits in vital pulp therapy, instrumentation, and anesthesia. Previous studies have shown that cryo-irrigation after NaOCl significantly reduces bacterial counts compared to NaOCl alone. Considering the potential benefits of these different irrigation protocols, the present study aims to evaluate and compare their effectiveness in reducing postoperative pain and bacterial load following single-visit root canal treatment of mandibular first molars diagnosed with symptomatic irreversible pulpitis. The aim of the study will be directed to evaluate postoperative pain and bacterial load reduction after application of different final irrigation protocols in single visit root canal treatment in patients with symptomatic irreversible pulpitis in first molar teeth. this study consists of 60 patients divided into 4 groups each group having 15 patients. control: Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min interventions: I1: Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min . I2: Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min. I3:Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Keywords

postoperative pain; bacterial load reduction

Outcome Measures

Primary Outcomes (1)

• Post-operative pain after each activation method in comparison to control group

  measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none (0): mild (1-3), severe (7-10).

  from 6 to 72 hours from the treatment .

Secondary Outcomes (1)

• bacterial load change after final irrigation protocol.

  "immediately after the intervention.

Study Arms (4)

Final irrigation by NaOcl at room temperature

ACTIVE COMPARATOR

Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min.

Procedure: Final irrigation by NaOcl at room temperature

Final irrigation by cryotreated NaOcl.

ACTIVE COMPARATOR

Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min

Procedure: Final irrigation by cryotreated NaOcl.

Final irrigation by preheated NaOcl.

ACTIVE COMPARATOR

Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min

Procedure: Final irrigation by preheated NaOcl

Final irrigation with ultrasonic activation of NaOcl.

ACTIVE COMPARATOR

Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min

Procedure: Final irrigation with ultrasonic activation of NaOcl

Interventions

Final irrigation by cryotreated NaOcl. PROCEDURE

Final irrigation by cryotreated NaOcl (2.6%) at 2-4 °C for 1 min

Also known as: cryotreated

Final irrigation by cryotreated NaOcl.

Final irrigation by preheated NaOcl PROCEDURE

Final irrigation by preheated 60°C(15) NaOcl (2.6%) for 1 min.

Also known as: preheated

Final irrigation by preheated NaOcl.

Final irrigation with ultrasonic activation of NaOcl PROCEDURE

Final irrigation with ultrasonic activation of NaOcl(2.6%) for 1 min

Final irrigation with ultrasonic activation of NaOcl.

Final irrigation by NaOcl at room temperature PROCEDURE

Final irrigation by NaOcl (2.6%) at room temperature 24 °C for 1 min

Final irrigation by NaOcl at room temperature

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with age range between 18 to 40.
• No sex predilection.
• Patients with symptomatic irreversible pulpitis.
• Patients able to sign informed consent.
• Restorable teeth
• Positive patient's acceptance for participating in the study.
• Type III distal and mesial canal of first mandibular molar.
• Mild to moderate (5-20) ° curvature according to Schneider

You may not qualify if:

• Pregnant females
• Medically compromised patients.
• Patients having analgesics before the treatment
• If antibiotic have been administrated during the past two weeks preoperatively.
• Patients having bruxism or clenching
• Patients having sever malocclusion associated with traumatic occlusion.
• Teeth that have:
• Peri-apical periodontitis Root resorption Pain on percussion Pulp stones or calcifications Previous endodontic treatment.
• Non-patent canals

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

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

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 25, 2025
• Study Start: July 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

EG (1)