Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Not Applicable

• Conditions: Symptomatic Periapical Periodontitis
• Interventions: Drug: Placebo; Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

• Registration Number: NCT03007342
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2016-12
• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-29
• Last Update Submitted: 2016-12-29
• Study Start: 2017-01
• Study First Posted: 2017-01-02
• Last Update Posted: 2017-01-02
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

1. Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
2. Mandibular posterior teeth with positive response to percussion.
3. Patients with non-contributory systemic condition.
4. Patients who can understand pain scales and able to sign informed consent.

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Exclusion Criteria

1. Patients allergic to penicillin.
2. Patients who have a draining sinus tract.
3. Retreatment cases.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Placebo	Oral tablet placebo every 12 hours for five days.
Experimental group	Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet	Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.

Primary Outcome Measures

Name	Time	Method
Post-operative pain.	Up to 7 days after endodontic treatment	Post-operative pain will be measured by a numerical rating scale (NRS).

Secondary Outcome Measures

Name	Time	Method
Swelling	7 days	The occurrence of Swelling will be measured by a questionnaire.