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

Ain Shams University135 enrolled

Overview

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: 1. Does Postoperative pain is different between the three groups? 2. Does level of substance P different between the three groups ?

* 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 2°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 2°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 2°C for 5 minutes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Post Operative Pain Inflammation

Interventions

cryotherapyOTHER

Cooling of irrigation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University

Cairo, Egypt

Outcomes

Primary Outcomes

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

Time frame: after 6 hours, 24 hours, 48 hours, 72 hours

Secondary Outcomes

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

Time frame: After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)

Data from ClinicalTrials.gov

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