Skip to main content
OpenTrials
Completed

NCT Number: NCT03033147

Effect of Preoperative Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Faculty of Dentistry

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement.
  • Mandibular posterior teeth.
  • 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.

Treatment and study plan

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Drug

2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment

Other names: Augmentin

oral placebo

Drug

placebo 30 minutes before root canal treatment

Primary outcomes

  1. Postoperative pain

    Time frame: Up to 7 days after endodontic treatment

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

Secondary outcomes

  1. Swelling

    Time frame: Up to 7 days after endodontic treatment

    The occurrence of Swelling will be measured by a questionnaire.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 26, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.