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

Primary Purpose

Symptomatic Periapical Periodontitis

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Oral placebo

About this trial

This is an interventional treatment trial for Symptomatic Periapical Periodontitis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cairo University Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Amoxicillin/Clavulanate Potassium

Placebo

Arm Description

Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment

placebo 30 minutes before root canal treatment

Outcomes

Primary Outcome Measures

Postoperative pain

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

Secondary Outcome Measures

Swelling

The occurrence of Swelling will be measured by a questionnaire.

Full Information

NCT ID

NCT03033147

First Posted

January 24, 2017

Last Updated

June 15, 2021

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03033147

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

October 18, 2019 (Actual)

Primary Completion Date

March 15, 2020 (Actual)

Study Completion Date

March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Symptomatic Periapical Periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Amoxicillin/Clavulanate Potassium

Arm Type

Experimental

Arm Description

Amoxicillin/Clavulanate Potassium 875 mg-125 mg orally 30 minutes before root canal treatment

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

placebo 30 minutes before root canal treatment

Intervention Type

Drug

Intervention Name(s)

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Other Intervention Name(s)

Augmentin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oral placebo

Intervention Description

placebo 30 minutes before root canal treatment

Primary Outcome Measure Information:

Title

Postoperative pain

Description

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

Time Frame

Up to 7 days after endodontic treatment

Secondary Outcome Measure Information:

Title

Swelling

Description

The occurrence of Swelling will be measured by a questionnaire.

Time Frame

Up to 7 days after endodontic treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nermeen NT Moushtaha, Postgraduate

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Suzan AW Amin, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shaimaa Gawdat, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Cairo University Faculty of Dentistry

City

Cairo

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

24967571

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.

Results Reference

background

PubMed Identifier

25954695

Citation

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.

Results Reference

background

PubMed Identifier

15920447

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.

Results Reference

background

PubMed Identifier

11487166

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. doi: 10.1097/00004770-200101000-00019.

Results Reference

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

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