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The purpose of this study is to assess the effect of preoperative Diclofenac Potassium (50 mg Cataflam) on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis.
This study aims to evaluate the effectiveness of preoperative administration of Diclofenac Potassium (50 mg Cataflam) compared to placebo, one hour before treatment, on the anesthetic success of buccal infiltration with 4% articaine with epinephrine 1:200,000 in mandibular molars with symptomatic irreversible pulpitis. Patients with moderate-to-severe pre-operative pain are selected. Full medical and dental history will be obtained from all patients treated during this study by the operator. Clinical diagnosis of symptomatic irreversible pulpitis is to be confirmed. The primary outcome is success of buccal infiltration using articaine.The secondary outcomes are pain on injection. Patients will be recruited from the outpatient clinic of Endodontics at the Faculty of Oral and Dental Medicine, Cairo University.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Potassium 50mg tab | Experimental | Diclofenac Potassium 50mg (Cataflam) 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 |
|---|---|---|
| Success of articaine buccal infiltration. | Success of buccal infiltration using articaine. It will be measured using Heft-Parker visual analogue scale. The success will be considered if patient experienced no or mild pain (Heft-Parker VAS rating less than 54mm) while the failure will be considered if patient experience moderate-or-severe pain (Heft-parker VAS rating greater than 54mm) during access into dentin, access into pulp chamber or instrumentation of the canals. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on injection | The secondary outcome is pain on injection. It will be measured by Heft-Parker visual analogue scale during local anesthesia administration. | Intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amatallah H Al-Rawhani, Postgraduate | Faculty of Oral and Dental Medicine/ Cairo University. | Principal Investigator |
| Dr. Suzan AW Amin, PhD | Faculty of Oral and Dental Medicine/ Cairo University. | Study Director |
| Shaima'a Gawdat, PhD | Faculty of Oral and Dental Medicine/ Cairo University. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24702239 | Background | Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22. | |
| 21692235 |
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| ID | Term |
|---|---|
| D011671 | Pulpitis |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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:
Diclofenac Potassium (50 mg, Cataflam) 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. |
|
| Prasanna N, Subbarao CV, Gutmann JL. The efficacy of pre-operative oral medication of lornoxicam and diclofenac potassium on the success of inferior alveolar nerve block in patients with irreversible pulpitis: a double-blind, randomised controlled clinical trial. Int Endod J. 2011 Apr;44(4):330-6. doi: 10.1111/j.1365-2591.2010.01833.x. |