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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Final irrigation by NaOCI at room temperature | Active Comparator | final irrigated using NaOCI (2.6%) at room temperature 24°C for 1 min. |
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| Final Irrigation by Cryotreated NaOCI | Active Comparator | final irrigated using NaOCI (2.6%) that Cryotreated at 2-4°C for 1 min. |
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| Final Irrigation by Preheated NaOCI | Active Comparator | final irrigated using NaOCI (2.6%) Preheated at 60°C for 1 min. |
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| Final Irrigation by Laser Activated NaOCI | Active Comparator | finally irrigated using NaOCI (2.6%) activated by laser for 1 min. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| final irrigation by NaOcl at room temperature | Procedure | final irrigation by NaOcl (2.6%) at room temperature 24°C for 1 min. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| bacterial load change after final irrigation protocol. | 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. | immediately after the intervention |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Future University in Egypt | Cairo | New Cairo | 11835 | Egypt |
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| final irrigation by Cryotreated NaOcl | Procedure | final irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min. |
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| final irrigation by preheated NaOcl | Procedure | final irrigation by preheated NaOcl (2.6%) at 60°C for 1 min. |
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| final irrigation by NaOCI activated by laser | Procedure | final irrigation by NaOCI (2.6%) activated by laser for 1 min. |
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