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

March 25, 2020 updated by: Ahmed Emad, Suez Canal University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Port Said, Egypt
        • Ahmed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: 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
EXPERIMENTAL: 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
Other: Cryotherapy
cold application
EXPERIMENTAL: 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
Other: Cryotherapy
cold application
EXPERIMENTAL: 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
Other: Cryotherapy
cold application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN
Time Frame: one week
post-operative pain is measured by using visual analogue scale (VAS) The modified VAS will include a 10 cm straight horizontal line numbered at each centimeter with following criteria: (0) for no pain, (1-3) for mild pain, (4-6) for moderate pain, (7-9) for severe tolerable pain and (10) for severe intolerable pain
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suez Canal University

Collaborators

Nelly AbdElsalam
Dalia Fayyad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

October 9, 2018

Study Completion (ACTUAL)

October 9, 2018

Study Registration Dates

First Submitted

March 20, 2020

First Submitted That Met QC Criteria

March 25, 2020

First Posted (ACTUAL)

March 27, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuezCanalU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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