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

Ain Shams University

Status: Completed

Conditions: Inflammation; Post Operative Pain

Treatments: Other: cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06106386

20720

Details and patient eligibility

About

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 ?

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 3 patient groups

Control Group

No Intervention group

Description:

Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite

Cryotherapy Group

Experimental group

Description:

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.

Treatment:

Other: cryotherapy

Final Flush group

Active Comparator group

Description:

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.

Treatment:

Other: cryotherapy