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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

Primary Purpose

Post Operative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Diclofenac Potassium
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Calcium Hydroxide, Diclofenac potassium, Intra-canal Medications

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Diclofenac Potassium

Calcium Hydroxide

Arm Description

In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.

Outcomes

Primary Outcome Measures

Incidence of Post operative pain assessed by VAS
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

Antibacterial effectiveness by measuring the bacterial count.
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.

Full Information

First Posted
October 28, 2020
Last Updated
November 3, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04622488
Brief Title
The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2020 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
Calcium Hydroxide, Diclofenac potassium, Intra-canal Medications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac Potassium
Arm Type
Active Comparator
Arm Description
In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration.
Arm Title
Calcium Hydroxide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diclofenac Potassium
Other Intervention Name(s)
Cataflam
Intervention Description
- 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.
Primary Outcome Measure Information:
Title
Incidence of Post operative pain assessed by VAS
Description
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.
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Antibacterial effectiveness by measuring the bacterial count.
Description
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.
Time Frame
pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heba El Far, Professor
Phone
+201282006589
Email
hebaelfar@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Morsy, doctorate
Phone
+201223980157
Email
dina.amorsy@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry Cairo University
City
Cairo
State/Province
El- Manial
ZIP/Postal Code
11553
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heba El Far, Professor
Phone
+201282006589
Email
hebaelfar@hotmail.com
First Name & Middle Initial & Last Name & Degree
Dina Morsy, Doctorate
Phone
+201223980157
Email
dina.amorsy@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Salma Aboul Azayam, bachelor

12. IPD Sharing Statement

Learn more about this trial

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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