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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Diclofenac Potassium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac Potassium<br>In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration. | Drug: Diclofenac Potassium<br>* - 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.<br>* Other names: Cataflam;|
| Experimental: Calcium Hydroxide<br> | Drug: Diclofenac Potassium<br>* - 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.<br>* Other names: Cataflam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcium Hydroxide, Diclofenac potassium, Intra-canal Medications