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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Potassium | Active Comparator | In the form of insitu gel can be applied as solution or suspension that undergoes gelation after administration. |
|
| Calcium Hydroxide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Potassium | Drug | - 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. |
| 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:
| 72 hours |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Medically compromised patients having significant systemic disorders. (ASA III or IV).
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heba El Far, Professor | Contact | +201282006589 | hebaelfar@hotmail.com | |
| Dina Morsy, doctorate | Contact | +201223980157 | dina.amorsy@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Cairo University | Cairo | El- Manial | 11553 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| pre-operatively(S1), after chemo-mechanical preparation(S2), and after 1 week(S3). |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |