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

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.

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.

Study Overview

• Status: Completed
• Conditions: Symptomatic Periapical Periodontitis
• Intervention / Treatment: Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet; Drug: Oral placebo

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.

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University faculty of dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Amoxicillin/Clavulanate Potassium; Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment	Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet; 2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment; Other Names: Augmentin
PLACEBO_COMPARATOR: Placebo; placebo 30 minutes before root canal treatment	Drug: Oral placebo; placebo 30 minutes before root canal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain will be measured by a numerical rating scale (NRS).	Up to 7 days after endodontic treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Swelling	The occurrence of Swelling will be measured by a questionnaire.	Up to 7 days after endodontic treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Nermeen NT Moushtaha, Postgraduate, Cairo University

Publications and helpful links

General Publications

• Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
• Akbar I. Efficacy of Prophylactic use of Antibiotics to Avoid Flare up During Root Canal Treatment of Nonvital Teeth: A Randomized Clinical Trial. J Clin Diagn Res. 2015 Mar;9(3):ZC08-11. doi: 10.7860/JCDR/2015/12046.5620. Epub 2015 Mar 1.
• Contardo L, Meneguzzi E, Cadenaro M, Di Lenarda R. Clinical evaluation of antibiotic prophylaxis before endodontic treatment of necrotic teeth. Minerva Stomatol. 2005 Mar;54(3):153-60. English, Italian.
• Pickenpaugh L, Reader A, Beck M, Meyers WJ, Peterson LJ. Effect of prophylactic amoxicillin on endodontic flare-up in asymptomatic, necrotic teeth. J Endod. 2001 Jan;27(1):53-6. doi: 10.1097/00004770-200101000-00019.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 18, 2019
• Primary Completion (ACTUAL): March 15, 2020
• Study Completion (ACTUAL): March 15, 2020

Study Registration Dates

• First Submitted: January 24, 2017
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (ESTIMATE): January 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Jaw Diseases; Periapical Diseases; Periodontitis; Periapical Periodontitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: CEBC-CU-2016-12-163

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No