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

Sponsor

Ain Shams University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06106386

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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:

Does Postoperative pain is different between the two groups?
Does level of substance P different between the two groups ?

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Inflammation	Other: cryotherapy	N/A

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 4°C continuously during our mechanical instrumentation. Then a final flush will be done with cold saline 4°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 4°C for 5 minutes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Intraradicular Cryotherapy on Post-operative Pain and the Level of Substance P in Patients With Symptomatic Apical Periodontitis

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control Group Conventional root canal treatment is done and irrigation will be done with 2.5% room temperature sodium hypochlorite
Experimental: Cryotherapy Group 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.	Other: cryotherapy Cooling of irrigation
Active Comparator: Final Flush group 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.	Other: cryotherapy Cooling of irrigation

Arm

Intervention/Treatment

No Intervention: Control Group

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

Experimental: Cryotherapy Group

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.

Other: cryotherapy

Cooling of irrigation

Active Comparator: Final Flush group

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.

Other: cryotherapy

Cooling of irrigation

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

Study Director: Maram F Obeid, Professor, Faculty of dentistry Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maram Obeid, Professor of Endodontics, Ain Shams University

ClinicalTrials.gov Identifier:

NCT06106386

Other Study ID Numbers:

20720

First Posted:

Oct 30, 2023

Last Update Posted:

Nov 3, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Maram Obeid, Professor of Endodontics, Ain Shams University

Additional relevant MeSH terms:

Inflammation

Pain, Postoperative

Study Results

No Results Posted as of Nov 3, 2023