Clinical Trial: Effect of Preoperative 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 Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Bl

Brief Summary: 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 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.

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.


Sponsor: Cairo University

Current Primary Outcome: Postoperative pain [ Time Frame: Up to 7 days after endodontic treatment ]

Postoperative pain will be measured by a numerical rating scale (NRS).


Original Primary Outcome: Same as current

Current Secondary Outcome: Swelling [ Time Frame: Up to 7 days after endodontic treatment ]

The occurrence of Swelling will be measured by a questionnaire.


Original Secondary Outcome: Same as current

Information By: Cairo University

Dates:
Date Received: January 24, 2017
Date Started:
Date Completion:
Last Updated: January 25, 2017
Last Verified: January 2017