Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Study Overview
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Brief Summary
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The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.

Detailed Description
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Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded. Clinical diagnosis of symptomatic apical periodontitis is to be confirmed. Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment). Root canal treatment will then be carried out in a single visit. Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.

Official Title
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Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial.

Conditions
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Symptomatic Periapical Periodontitis

Intervention / Treatment
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* Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
* Drug: Oral placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement. Mandibular posterior teeth. Patients with non-contributory systemic condition. Patients who can understand pain scales and able to sign informed consent. Exclusion Criteria: Patients allergic to penicillin. Patients who have a draining sinus tract. Retreatment cases.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amoxicillin/Clavulanate Potassium<br>Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment | Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet<br>* 2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment<br>* Other names: Augmentin;|
| Placebo Comparator: Placebo<br>placebo 30 minutes before root canal treatment | Drug: Oral placebo<br>* placebo 30 minutes before root canal treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be measured by a numerical rating scale (NRS). | Up to 7 days after endodontic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Swelling | The occurrence of Swelling will be measured by a questionnaire. | Up to 7 days after endodontic treatment |