Effect of 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 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. After single-visit root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination) or control group (taking placebo tablet). 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 Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A 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: 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 with positive response to percussion. 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: Experimental group<br>Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days. | Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet<br> <br> |
| Placebo Comparator: control group<br>Oral tablet placebo every 12 hours for five days. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain. | Post-operative 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. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amoxicillin, clavulanic acid, Periapical periodontitis, Post-operative pain