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

Not Applicable

Completed

• Conditions: Post Operative Pain; Inflammation
• Interventions: Other: cryotherapy

• Registration Number: NCT06106386
• Lead Sponsor: Ain Shams University

Brief Summary

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 ?

Detailed Description

* 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 Timeline

• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Study Start: 2024-01-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Final Flush group	cryotherapy	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.
Cryotherapy Group	cryotherapy	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.

Primary Outcome Measures

Name	Time	Method
Level of post operative pain	after 6 hours, 24 hours, 48 hours, 72 hours	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

Secondary Outcome Measures

Name	Time	Method
Level of substance P	After access cavity, after finishing mechanical perpetration, before obturation(after 3 days)	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt