Clinical Trial: Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

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 Summary:

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.

Sponsor: Cairo University

Current Primary Outcome: Post-operative pain. [ Time Frame: Up to 7 days after endodontic treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Swelling [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: December 19, 2016
Date Started: January 2017
Date Completion:
Last Updated: December 29, 2016
Last Verified: December 2016