Effect of Intracanal Cryotherapy Versus Laser Application on Postoperative-pain and Bacterial Load Reduction in Single Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis in Mandibular First Molar Teeth (Randomized Control Trial)

NCT07627867 | Active Not Recruiting

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

Brief Summary

This randomized controlled clinical trial investigates the Effect of Intracanal Cryotherapy Versus Laser Application on Post-Operative Pain and Bacterial Load Reduction in Single-Visit Root Canal Treatment in Patients with Symptomatic Irreversible Pulpitis in Mandibular First Molars. Sixty patients aged 18-40 years with restorable mandibular first molars diagnosed with symptomatic irreversible pulpitis will be enrolled at the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt. Participants will be randomly allocated into four groups: Group 1 (control) will receive final irrigation with 2.6% sodium hypochlorite (NaOCl) at room temperature (24°C), Group 2 will receive cryotreated NaOCl (2-4°C), Group 3 will receive preheated NaOCl (60°C), and Group 4 will receive laser-activated NaOCl, each applied for one minute. The study will be double-blind for both the operator and the patient. Post-operative pain will be assessed using a Numerical Rating Scale (0-10) at 6, 12, 24, 48, and 72 hours post-treatment. Bacterial load reduction will be measured microbiologically at three stages: after access cavity preparation, after instrumentation, and after final irrigation. Statistical analysis will be performed using SPSS version 24 and Minitab version 16, with a significance level of p \< 0.05. The study has received ethical approval from the Future University Ethics Committee and is conducted without external funding.

Conditions

Symptomatic Irreversible Pulpitis (SIP)

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 NaOCI at room temperature

ACTIVE COMPARATOR

final irrigated using NaOCI (2.6%) at room temperature 24°C for 1 min.

Procedure: final irrigation by preheated NaOcl

Final Irrigation by Cryotreated NaOCI

ACTIVE COMPARATOR

final irrigated using NaOCI (2.6%) that Cryotreated at 2-4°C for 1 min.

Procedure: final irrigation by NaOCI activated by laser

Final Irrigation by Preheated NaOCI

ACTIVE COMPARATOR

final irrigated using NaOCI (2.6%) Preheated at 60°C for 1 min.

Procedure: final irrigation by Cryotreated NaOcl

Final Irrigation by Laser Activated NaOCI

ACTIVE COMPARATOR

finally irrigated using NaOCI (2.6%) activated by laser for 1 min.

Procedure: final irrigation by NaOcl at room temperature

Interventions

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 Laser Activated NaOCI

final irrigation by Cryotreated NaOcl PROCEDURE

final irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min.

Final Irrigation by Preheated NaOCI

final irrigation by preheated NaOcl PROCEDURE

final irrigation by preheated NaOcl (2.6%) at 60°C for 1 min.

Final irrigation by NaOCI at room temperature

final irrigation by NaOCI activated by laser PROCEDURE

final irrigation by NaOCI (2.6%) activated by laser for 1 min.

Final Irrigation by Cryotreated NaOCI

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 40 years.
• Patients able to understand and sign the informed consent form.
• Patients who positively accept to participate in the study.
• Patients diagnosed with symptomatic irreversible pulpitis in a restorable mandibular first molar.
• The affected tooth must have a mesial and distal root canal configuration classified as Type III according to Vertucci's classification.
• The root curvature of the involved canals must be mild to moderate (5-20°), as measured by Schneider's method.
• No sex predilection.

You may not qualify if:

• Patients who are pregnant or lactating.
• Medically compromised patients (e.g., with systemic conditions that contraindicate dental treatment or affect pain perception).
• Patients who have taken any analgesic medication within 8 hours prior to the appointed treatment.
• Patients who have taken antibiotics within the two weeks prior to the preoperative assessment.
• Patients with parafunctional habits such as bruxism or clenching.
• Patients with severe malocclusion associated with traumatic occlusion.
• Teeth exhibiting any of the following:
• Pain on percussion.
• A diagnosis of peri-apical periodontitis or a peri-radicular lesion.
• Internal or external root resorption.
• Pulp stones or significant canal calcifications.
• Evidence of previous endodontic treatment.
• Teeth with non-patent canals or canals that cannot be negotiated.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Location

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: May 31, 2026
• First Posted: June 4, 2026
• Study Start: July 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

EG (1)