Effect of Intracanal Cryotherapy Versus Laser Application on Postoperative-pain and Bacterial Loa… (NCT07627867) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
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)
Egypt60 participantsStarted 2025-07-01
Plain-language 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.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Post-operative pain after each activation method in comparison to control group