Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryoirrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

January 27, 2021 updated by: Yousra Khaled Mohamed Ezzat, Cairo University

Evaluation of Post-operative Pain and Expression of IL-8 Using Ketolac or Cryo-irrigation as a Final Flush in Single Visit Endodontic Treatment in Teeth With Symptomatic Irreversible Pulpitis and Apical Periodontitis.Randomized Clinical Trial.

To compare the effect of cryotherapy versus ketorolac tromethamine irrigating solutions used as a final flush in single visit endodontic treatment in mandibular molars, with symptomatic irreversible pulpitis and apical periodontitis on the:

  • Intensity of post-operative pain in patients with symptomatic irreversible pulpitis
  • Reduction of expression of Interleukin-8 (IL-8) post-instrumentation using ELISA
  • The analgesic intake following endodontic treatment for post-operative pain relief.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main rationale of endodontic treatment is to eliminate micro-organisms from the infected root canal system by adequate chemo-mechanical debridement followed by a three-dimensional hermetic seal to provide a conductive environment for peri-radicular healing. However, Even with the utmost care in performing root canal therapy, it has been reported that the prevalence of post-operative pain after single visit endodontic treatment has been reported to be between 3 to 58%.

Non-steroidal anti-inflammatory drugs (NSAIDs) and Steroids have been advocated for control of post-operative pain following root canal treatment in teeth with symptomatic irreversible pulpitis. Ketorolac tromethamine, a potent NSAID that is over 400 times a selective inhibitor for COX-1 over COX-2 as compared to other drugs. In a recent study by (Evangelin et al 2019), assessing the influence of ketorolac tromethamine and dexamethasone when used as root canal irrigant on the expression of substance P and IL-8; showed that dexamethasone irrigation achieved the least post-operative pain and the least requirements for analgesics, whilst ketorolac tromethamine had better control on the expression of substance P and IL-8 as compared to dexamethasone.

Additionally, a more recent strategy for reduction of post-operative pain is cryotherapy. Such treatment modality is aimed to expose the body to very cold temperature, resulting in vasoconstriction and decreased permeability thus reducing the amount of fluid leaking into the peri-radicular tissues as exudate which commonly occur after chemo-mechanical preparation. Analgesia is closely related to the nerve conduction velocity of the nociceptive sensory nerve fibers. Thus, cooling induces analgesia by slowing the velocity of nerve conduction as well as decreasing the activation threshold of tissue nociceptors resulting in cold-induced neuropraxia. Thus the analgesic effect of cooling is produced by combination of decreased release of chemical mediators of pain and a slower propagation of neural pain signals.

In our study, ketorolac tromethamine, dexamethasone and cryotherapy are supposed to be used as root canal irrigants during root canal treatment to assess their effectiveness in reducing post-operative pain following single visit endodontic treatment in patients with symptomatic irreversible pulpitis, as well as their efficacy in reducing the expression of IL-8. Randomized clinical trials are the gold standard of interventional trials resulting in the highest level of evidence that contributes effectively in the clinical decision-making process as to the best intervention for the patient's condition providing the most effective clinical outcomes for the satisfaction of the patient. Thus the aim of the study is to compare the effect of using cryotherapy versus ketorolac tromethamine and dexamethasone irrigating solutions on the intensity of post-operative pain and reduction of expression of Interleukin-8(IL-8) post-instrumentation in patients with symptomatic irreversible pulpitis.

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 1

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • - Medically free patients
  • Age between 18-40 years old
  • Males or females
  • Participants able to understand Visual Analogue Scale (the pain chart diary) and sign the informed consent ( Appendix I,II).

  • Mandibular permanent molar teeth:

    • Diagnosed clinically with symptomatic irreversible pulpitis associated with apical periodontitis.
    • Presence of spontaneous pain and sharp pain to cold tester (ethyl-chloride) that lingers after removal of the stimulus compared to the contra-lateral tooth
    • Tenderness to percussion with normal periapical radiographic appearance or slight widening of the lamina dura

Exclusion Criteria:

  • - Participants allergic to NSAIDS
  • Pregnant females
  • Participants having significant systemic disorder
  • If analgesics or antibiotics have been taken by the patient during the past 24 hours pre-operatively.
  • Participants with psychological disturbances
  • Participants with bruxism or clenching
  • Participants having acute pain in more than one mandibular molar

  • Participants with mandibular molar teeth showing:

    • Swelling or fistulous tract
    • Acute or chronic periapical abscess
    • Mobility greater than grade I
    • Periodontitis
    • Previous endodontic treatment or non-restorability

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryothrapy
5 ml Saline at low temperature (2.5°C) will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
Drug: Ketorolac Tromethamine
final rinse with non-steriodal anti-inflammatory drug or cold saline during single visit endodontic treatment
Other Names:
  • Cryotherapy
Experimental: Ketroloc tromethamine
2ml 30 mg Ketroloc tromethamine will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
Drug: Ketorolac Tromethamine
final rinse with non-steriodal anti-inflammatory drug or cold saline during single visit endodontic treatment
Other Names:
  • Cryotherapy
Placebo Comparator: Saline at room temperature
30 ml Saline at room temperature will be used as intra-canal irrigantion during single visit endodontics treatment, to study the effect on reduction of post-operative pain and expression of IL-8.
Drug: Ketorolac Tromethamine
final rinse with non-steriodal anti-inflammatory drug or cold saline during single visit endodontic treatment
Other Names:
  • Cryotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of post-operative pain
Time Frame: 24 hours following endoodnitc treatment
using the visual analogue scale
24 hours following endoodnitc treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-8 level
Time Frame: during root canal treatment
using the ELISA
during root canal treatment
Analgesic intake
Time Frame: first 24 hours after completion of endodontic treatment
counting the number of analgesic tablets taken after endodontic treatment
first 24 hours after completion of endodontic treatment

Collaborators and Investigators

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

Sponsor

Cairo University

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 (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 24, 2021

First Submitted That Met QC Criteria

January 27, 2021

First Posted (Actual)

February 2, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CairoU0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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