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Clinical Trial 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.


Clinical Trial 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT03007342
Study type Interventional
Source Cairo University
Contact Ahmed Gomaa, Postgraduate
Phone 01006610083
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date January 2017

See also
  Status Clinical Trial Phase
Completed NCT03033147 - Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain N/A
Completed NCT04324398 - Influence of Intra-Canal Cryotherapy on Post-Endodontic Pain and Interleukin-6 Expression Using Different Irrigation Protocols: A Randomized Clinical Trial N/A
Not yet recruiting NCT03033472 - Effect of Preoperative Clindamycin on Postoperative Endodontic Pain Phase 2/Phase 3