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 · tracked via the Priya Life Science Egypt tracker

Sponsor

Future University in Egypt

Phase

Not applicable

Started

2025-07-01

Last updated

2026-06-04

Condition(s) studied

Symptomatic Irreversible Pulpitis (SIP)

Investigational drug(s) / intervention(s)

final irrigation by NaOcl at room temperaturefinal irrigation by Cryotreated NaOclfinal irrigation by preheated NaOclfinal irrigation by NaOCI activated by laser

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

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

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

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

40 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Post-operative pain after each activation method in comparison to control group — from 6 to 72 hours from the treatment
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).

Trial sites (1)

Facility	City	Region	Status
Future University in Egypt	Cairo	New Cairo

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07627867 on ClinicalTrials.gov ↗ ← All trials in Egypt