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NCT Number: NCT07627867

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)

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Symptomatic Irreversible Pulpitis (SIP)

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

Cairo, New Cairo, 11835, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 Cryotreated NaOcl

Procedure

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

final irrigation by preheated NaOcl

Procedure

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

final irrigation by NaOCI activated by laser

Procedure

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

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. bacterial load change after final irrigation protocol.

    Time frame: immediately after the intervention

    Recording the percentage of bacterial load reduction by collecting samples by paper points, first sample after access cavity and before Root canal treatment. second sample after mechanical instrumentation third sample after final irrigation.

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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