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

Inflammation Clinical Trial

Official title:

The Impact of Using Cold Irrigation on Postoperative Endodontic Pain and Substance P Level: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106386
• Other study ID #: 20720
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: September 2024

Study information

• Verified date: June 2024
• Source: Ain Shams University
• Contact: Reem M Sharaf, Bachelor
• Phone: 01069990341
• Email: reem.m.sharaf[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 ?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• cryotherapy
Cooling of irrigation

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)