The Effect of Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P

Study Overview
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Brief Summary
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The aim of this clinical trial is to evaluate the effect of using intra-radicular cryotherapy technique in the form of irrigation with cold sodium hypochlorite The main questions to answer are: Does Postoperative pain is different between the two groups? Does level of substance P different between the two groups ?

Detailed Description
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The patients will be randomly divided into three groups Group 1: control group (n=25) Regular root canal treatment with regular irrigant will be used. Group 2: (n=25) Intraradicular cryotherapy will be performed where : Normal root canal treatment will be done with irrigation using sodium hypochlorite cooled to 4°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 4°C for 5 minutes. Group 3: (n=25) Normal root canal treatment will be done with irrigation using sodium hypochlorite at room temperature during our mechanical instrumentation. Then a final flush will be done with cold saline 4°C for 5 minutes.

Official Title
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The Effect of Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P in Patients With Symptomatic Apical Periodontitis

Conditions
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Post Operative Pain, Inflammation

Intervention / Treatment
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* Other: cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients that will be diagnosed with symptomatic apical periodontitis Single-rooted premolars (radiographically and clinically assessed) Medically free patients. Teeth with mature apex Exclusion Criteria: Patients with other pulpal diagnosis. Medically compromised patients. Pregnant females. Patients taking analgesics or anti-inflammatory drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite | |
| Experimental: Cryotherapy Group<br>Root canal treatment is done and irrigation is done with cooled sodium hypochlorite ( 2- 4°C) through out the visits and final flush with 2- 4°C cold saline will be used for 5 minutes. | Other: cryotherapy<br>* Cooling of irrigation<br>|
| Active Comparator: Final Flush group<br>Root canal treatment is done and irrigation is done with sodium hypochlorite at room temperature through out the visits then final flush with 2- 4°C cold saline will be used for 5 minutes. | Other: cryotherapy<br>* Cooling of irrigation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of post operative pain | On visual analogue scale (VAS) questionnaire, patients will report their level of pain 0° refers for no pain, and the 100° degree refers for unbearable pain | after 6 hours, 24 hours, 48 hours, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of substance P | apical fluid sample will be taken using sterilized, medium sized paper point (Diadent Korea, Seoul, Korea) will be inserted into the periapical area and left in place for 30 seconds and the sample will be placed into a 1.5-mL Eppendorf tube containing 100 _L of Tris-HCl buffer, pH 7.5, with 0.15 M NaCl and 1 mM CaCl2; the tubes will be placed on a shaker at room temperature for 3 hours and then stored at -70°C | After access cavity, after finishing mechanical perpetration, before obturation(after 3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryotherapy, Substance P, Apical periodontitis, Post Operative Pain