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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06106386
Enrollment
135
Registered
2023-10-30
Start date
2024-01-01
Completion date
2024-03-01
Last updated
2024-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation, Post Operative Pain

Keywords

Cryotherapy, Substance P, Apical periodontitis, Post Operative Pain

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.

Interventions

OTHERcryotherapy

Cooling of irrigation

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Level of post operative painafter 6 hours, 24 hours, 48 hours, 72 hoursOn 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

MeasureTime frameDescription
Level of substance PAfter 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026