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

Symptomatic Periapical Periodontitis Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033147
• Other study ID #: CEBC-CU-2016-12-163
• Status: Completed
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Symptomatic Periapical Periodontitis

Intervention

Drug:
• Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
• Oral placebo
placebo 30 minutes before root canal treatment

Locations

Country	Name	City	State
Egypt	Cairo University Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2018 Sep 27;9:CD010136. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	Postoperative pain will be measured by a numerical rating scale (NRS).	Up to 7 days after endodontic treatment
Secondary	Swelling	The occurrence of Swelling will be measured by a questionnaire.	Up to 7 days after endodontic treatment