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Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Primary Purpose

Symptomatic Periapical Periodontitis

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Placebo

About this trial

This is an interventional treatment trial for Symptomatic Periapical Periodontitis focused on measuring Amoxicillin, clavulanic acid, Periapical periodontitis, Post-operative pain

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 with positive response to percussion.
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

control group

Arm Description

Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.

Oral tablet placebo every 12 hours for five days.

Outcomes

Primary Outcome Measures

Post-operative pain.

Post-operative 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

NCT03007342

First Posted

December 19, 2016

Last Updated

December 29, 2016

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03007342

Brief Title

Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

Official Title

Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2017 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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. 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.

6. Conditions and Keywords

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

Symptomatic Periapical Periodontitis

Keywords

Amoxicillin, clavulanic acid, Periapical periodontitis, Post-operative pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

Oral tablet 1000 mg of Amoxicillin/ clavulanic acid combination every 12 hours for five days.

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

Oral tablet placebo every 12 hours for five days.

Intervention Type

Drug

Intervention Name(s)

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Post-operative pain.

Description

Post-operative 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

7 days

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 with positive response to percussion. 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmed Gomaa, Postgraduate

Phone

01006610083

ahmed.eltoukhy@dentistry.cu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmed Gomaa, Postgraduate

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

khaled Ezzat, Professor

Organizational Affiliation

Cairo University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Suzan AW Amin, PhD

Organizational Affiliation

Cairo University

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11491635

Citation

Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. J Endod. 2001 Feb;27(2):117-23. doi: 10.1097/00004770-200102000-00016.

Results Reference

background

PubMed Identifier

8734709

Citation

Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1996 May;81(5):590-5. doi: 10.1016/s1079-2104(96)80054-0.

Results Reference

background

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

26946211

Citation

Arteagoitia MI, Barbier L, Santamaria J, Santamaria G, Ramos E. Efficacy of amoxicillin and amoxicillin/clavulanic acid in the prevention of infection and dry socket after third molar extraction. A systematic review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e494-504. doi: 10.4317/medoral.21139.

Results Reference

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Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain

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