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

NCT04324398 | Completed

• 1 other identifier: SuezCanalU
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Symptomatic Periapical Periodontitis

Keywords

Cryotherapy; Interleukins; Postoperative pain; Sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• 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

  one week

Study Arms (4)

group I (control )

NO INTERVENTION

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

Group II

EXPERIMENTAL

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

Group III

EXPERIMENTAL

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

Group IV

EXPERIMENTAL

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

Interventions

Cryotherapy OTHER

cold application

Group II; Group III; Group IV

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suez Canal University: lead
• Nelly AbdElsalam: collaborator
• Dalia Fayyad: collaborator

Study Sites (1)

Ahmed

Port Said, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryotherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 27, 2020
• Study Start: December 1, 2017
• Primary Completion: October 9, 2018
• Study Completion: October 9, 2018
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

EG (1)