The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect

November 3, 2020 updated by: Salma Mohamed Aboul Azayem, Cairo University

The Effect of Diclofenac Potassium Insitu Gel Versus Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect in Lower Non Vital Premolars With Symptomatic Apical Periodontitis

The aim of this study is to clinically compare the post-operative pain level and antibacterial effect when using the Diclofenac Potassium Insitu gel versus calcium hydroxide as an intra- canal medication in patients with apical periodontitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

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 Contact

Study Contact Backup

Study Locations

    • El- Manial
      • Cairo, El- Manial, Egypt, 11553
        • Faculty of Dentistry Cairo University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salma Aboul Azayam, bachelor

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18-45 years old.
  • Males/Females.
  • Lower permanent premolars with: Non-Vital pulps. Sensitive to percussion. Negative response to cold pulp tester (ethyl chloride spray1). Apical periodontitis
  • Systemically healthy patients (ASA I or II).

Exclusion Criteria:

  • Medically compromised patients having significant systemic disorders. (ASA III or IV).

    • History of intolerance to NSAIDS.
    • Patients with two or more adjacent teeth requiring endodontic treatment.
    • Teeth with :
  • Association with swelling or fistulous tract.
  • Acute or chronic peri-apical abscess. Mobility Grade II or III.
  • Pocket depth more than 5mm.
  • Previous root canal therapy.
  • Non-restorability
  • Patients with a contraindication for the use of DFK or those known to be allergic to any of the study medications.eg. Patient with kidney problems.

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: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Diclofenac Potassium
In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.
- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation.
Other Names:
  • Cataflam
EXPERIMENTAL: Calcium Hydroxide
- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation.
Other Names:
  • Cataflam

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Post operative pain assessed by VAS
Time Frame: 72 hours

Post-operative pain following chemo-mechanical endodontic treatment will be measured.

A pain chart using visual analogue scale (VAS) will be used to record the patients' pain levels. The VAS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow:

  • 0, "no pain"
  • 1-3, "mild pain"
  • 4-6, "moderate pain"
  • 7-10, "severe pain" Using the VAS chart, the patient will choose and record the most appropriate pain rating according to the pain intensity endured.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibacterial effectiveness by measuring the bacterial count.
Time Frame: pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).
The bacterial count method will be used. Once the samples will arrive to the microbiology department, Cairo University, the tubes containing the thioglycolate 14(transport medium) with the paper points will be placed in micro centrifuge and vortexed for 30 sec. One hundred (100) μl aliquots of the vortexed samples will be placed in a new sterile tube containing 1 ml of thioglycolate to obtain 1/10 concentration to assess the microbial load of common aerobes and anaerobes found in each root canal. The effect of the treatment in each group, the initial colonizers (S1), the mechanical preparation (S2) and after the intra-canal medication (S3) will be compared.
pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).

Collaborators and Investigators

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

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)

November 1, 2020

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

September 1, 2022

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

October 1, 2020

More Information

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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