- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04622488
The Effect of Diclofenac Potassium Insitu Gel Vs Calcium Hydroxide as Intra-canal Medications on Post-operative Pain and Anti-bacterial Effect
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heba El Far, Professor
- Phone Number: +201282006589
- Email: hebaelfar@hotmail.com
Study Contact Backup
- Name: Dina Morsy, Doctorate
- Phone Number: +201223980157
- Email: dina.amorsy@dentistry.cu.edu.eg
Study Locations
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El- Manial
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Cairo, El- Manial, Egypt, 11553
- Faculty of Dentistry Cairo University
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Contact:
- Heba El Far, Professor
- Phone Number: +201282006589
- Email: hebaelfar@hotmail.com
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Contact:
- Dina Morsy, Doctorate
- Phone Number: +201223980157
- Email: dina.amorsy@dentistry.cu.edu.eg
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Principal Investigator:
- Salma Aboul Azayam, bachelor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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:
|
EXPERIMENTAL: Calcium Hydroxide
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- 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:
|
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:
|
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).
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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.
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pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Diclofenac
Other Study ID Numbers
- ENDO 3-7-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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