Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Preoperative Diclofenac Potassium on Articaine Buccal Infitration Success in Mandibular Molars With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

Conditions
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Pulpitis - Irreversible, Anesthesia, Local

Intervention / Treatment
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* Drug: Diclofenac Potassium 50mg Tab
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with active pain (moderate-to-severe) in mandibular molars. Patients with prolonged response to cold testing and electric pulp tester. Patient with the ability to understand and use pain scales. Patient with vital coronal pulp tissue on access. Patient who accept to enroll to the study. Exclusion Criteria: Patients' allergies or any other contraindication to diclofenac potassium or articaine. Pregnant and lactating females. Patients having pain medication in the last 6 hours. Patient has more than one symptomatic mandibular tooth in the same quadrant. Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments. Patients with active peptic ulcer and gastrointestinal disorders. Patients with history of bleeding problems or anticoagulant use within the last month.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diclofenac Potassium 50mg tab<br>Diclofenac Potassium 50mg (Cataflam) tablet to be administered one hour before treatment. | Drug: Diclofenac Potassium 50mg Tab<br>* A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.<br>* Other names: Cataflam 50mg;|
| Placebo Comparator: Placebo<br>Placebo to be administered one hour before treatment. | Drug: Placebo<br>* A placebo will be taken one hour before initiation of endodontic treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulpitis, irreversible Pulpitis, Hot tooth, Cataflam, Diclofenac Potassium, Preoperative, Premedication, Analgesic, Local anesthesia, Articaine, Buccal infiltration