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

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ClinicalTrials.gov Identifier: NCT04622488
Recruitment Status : Not yet recruiting
First Posted : November 10, 2020
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Salma Mohamed Aboul Azayem, Cairo University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post Operative Pain Drug: Diclofenac Potassium Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Drug: Diclofenac Potassium
- 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 Name: Cataflam
Experimental: Calcium Hydroxide Drug: Diclofenac Potassium
- 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 Name: Cataflam


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622488


Contacts
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Contact: Heba El Far, Professor +201282006589 hebaelfar@hotmail.com
Contact: Dina Morsy, doctorate +201223980157 dina.amorsy@dentistry.cu.edu.eg

Locations
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Egypt
Faculty of Dentistry Cairo University
Cairo, El- Manial, Egypt, 11553
Contact: Heba El Far, Professor    +201282006589    hebaelfar@hotmail.com   
Contact: Dina Morsy, Doctorate    +201223980157    dina.amorsy@dentistry.cu.edu.eg   
Principal Investigator: Salma Aboul Azayam, bachelor         
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Salma Mohamed Aboul Azayem, Prinicipal Investegator, Cairo University
ClinicalTrials.gov Identifier: NCT04622488    
Other Study ID Numbers: ENDO 3-7-2
First Posted: November 10, 2020    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Salma Mohamed Aboul Azayem, Cairo University:
Calcium Hydroxide
Diclofenac potassium
Intra-canal Medications
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action