Back to resultsInfluence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Primary Purpose
Symptomatic Periapical Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cryotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Periapical Periodontitis focused on measuring Cryotherapy, Interleukins, Postoperative pain, Sodium hypochlorite
Eligibility Criteria
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.
Sites / Locations
- Ahmed
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
group I (control )
Group II
Group III
Group IV
Arm Description
irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping, between each file and till the final rinse
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
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
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
Outcomes
Primary Outcome Measures
PAIN
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04324398
First Posted
March 20, 2020
Last Updated
March 25, 2020
Sponsor
Suez Canal University
Collaborators
Nelly AbdElsalam, Dalia Fayyad
1. Study Identification
Unique Protocol Identification Number
NCT04324398
Brief Title
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Official Title
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suez Canal University
Collaborators
Nelly AbdElsalam, Dalia Fayyad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Periapical Periodontitis
Keywords
Cryotherapy, Interleukins, Postoperative pain, Sodium hypochlorite
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group I (control )
Arm Type
No Intervention
Arm Description
irrigation with 5% sodium hypochlorite at room temperature from the beginning of cleaning and shaping, between each file and till the final rinse
Arm Title
Group II
Arm Type
Experimental
Arm Description
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
Arm Title
Group III
Arm Type
Experimental
Arm Description
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
Arm Title
Group IV
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Intervention Description
cold application
Primary Outcome Measure Information:
Title
PAIN
Description
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
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ahmed
City
Port Said
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial
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