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The purpose of this study is to assess the effect of preoperative a single-dose of 50 mg diclofenac potassium on postoperative endodontic pain in mandibular molars with symptomatic irreversible pulpitis.
Patients with moderate-to-severe preoperative pain are selected. Patients receive either a single-dose of 50 mg diclofenac potassium (group A) or a placebo tablet as a control (group B). All patients receive the assigned premedication one hour before single-visit root canal treatment. Postoperative endodontic pain is measured at the following time points: 6 , 12,24,48 h after treatment. The incidence of analgesic intake is also recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Potassium 50mg tab | Experimental | Diclofenac Potassium 50mg tablet to be administered one hour before treatment. |
|
| Placebo | Placebo Comparator | Placebo to be administered one hour before treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac Potassium 50mg Tab. | Drug | A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative endodontic pain | Pain after completion root canal treatment measured by Heft-parker visual analogue scale. | Up to 2 days after endodontic treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic intake | The incidence of analgesic intake is recorded | Up to 2 days after endodontic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amatallah H Al-Rawhani, Pos | Faculty of Oral and Dental Medicine/ Cairo University. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dentistry Faculty | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27080115 | Background | Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12. | |
| 26957785 | Background | Metri M, Hegde S, Bhandi S. Effect of pretreatment diclofenac sodium on postendodontic pain: A randomised controlled trial. J Conserv Dent. 2016 Jan-Feb;19(1):7-10. doi: 10.4103/0972-0707.173183. |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D011183 | Postoperative Complications |
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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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The patients will be randomly divided into 2 groups:
Experimental group:
50 mg Diclofenac Potassium to be administered one hour before treatment.
Control group:
Placebo to be administered one hour before treatment.
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| Placebo | Drug | A placebo will be taken one hour before initiation of endodontic treatment. |
|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |