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

NCT ID: NCT06106386

Last Updated: 2024-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-03-01

Brief Summary

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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

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* 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.

Conditions

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Post Operative Pain Inflammation

Keywords

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Cryotherapy Substance P Apical periodontitis Post Operative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

cryotherapy

Intervention Type OTHER

Cooling of irrigation

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.

Group Type ACTIVE_COMPARATOR

cryotherapy

Intervention Type OTHER

Cooling of irrigation

Interventions

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cryotherapy

Cooling of irrigation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Maram Obeid

Professor of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maram F Obeid, Professor

Role: STUDY_DIRECTOR

Faculty of dentistry Ain Shams University

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Sharaf RMA, Abdelrahman TY, Obeid MF. The impact of using cold irrigation on postoperative endodontic pain and substance P level: a randomized clinical trial. Odontology. 2025 Jun 18. doi: 10.1007/s10266-025-01131-3. Online ahead of print.

Reference Type DERIVED
PMID: 40533695 (View on PubMed)

Other Identifiers

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20720

Identifier Type: -

Identifier Source: org_study_id