Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial

NCT ID: NCT04324398

Last Updated: 2020-03-27

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-10-09

Brief Summary

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the study was to evaluate the effect of intra-canal cryotherapy on post-endodontic pain and interleukin-6 expression in teeth with symptomatic apical periodontitis using different irrigation protocols.

Detailed Description

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Conditions

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Symptomatic Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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group I (control )

irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping, between each file and till the final rinse

Group Type NO_INTERVENTION

No interventions assigned to this group

Group II

irrigation with 5% cold sodium hypochlorite (2-5°C) from the beginning of cleaning and shaping and between each file. Final rinse was done by 20 mL of 5% cold sodium hypochlorite (2-5°C) for 5 minutes

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

cold application

Group III

irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping and between each file. Then final rinse with 20 mL of 5% cold sodium hypochlorite (2-5°C) for 5 minutes

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

cold application

Group IV

irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping and between each file. Then final rinse with 20 mL of cold saline (2-5°C) for 5 minutes

Group Type EXPERIMENTAL

Cryotherapy

Intervention Type OTHER

cold application

Interventions

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Cryotherapy

cold application

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Anterior or premolar single canal in single rooted teeth.
* Patients aged 20 to 50 years.

Exclusion Criteria

* Patients under anti-inflammatory medication, immune-suppressive chemotherapy or any antibiotic medication for the last 2 months.
* Pregnant or lactating females.
* Teeth with endo-perio lesions.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nelly AbdElsalam

UNKNOWN

Sponsor Role collaborator

Dalia Fayyad

UNKNOWN

Sponsor Role collaborator

Suez Canal University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Emad

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ahmed

Port Said, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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SuezCanalU

Identifier Type: -

Identifier Source: org_study_id

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