NCT03007342

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 2, 2017

Status Verified

December 1, 2016

Enrollment Period

11 months

First QC Date

December 19, 2016

Last Update Submit

December 29, 2016

Conditions

Symptomatic Periapical Periodontitis

Keywords

Amoxicillinclavulanic acidPeriapical periodontitisPost-operative pain

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain.

    Post-operative pain will be measured by a numerical rating scale (NRS).

    Up to 7 days after endodontic treatment

Secondary Outcomes (1)

  • Swelling

    7 days

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Drug: Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet

control group

PLACEBO COMPARATOR

Oral tablet placebo every 12 hours for five days.

Drug: Placebo

Interventions

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tabletDRUG
Experimental group
PlaceboDRUG
control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients allergic to penicillin.
  • Patients who have a draining sinus tract.
  • Retreatment cases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 11491635BACKGROUND

  • 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.

    PMID: 8734709BACKGROUND

  • 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.

    PMID: 24967571BACKGROUND

  • 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.

    PMID: 26946211BACKGROUND

MeSH Terms

Conditions

Periapical PeriodontitisPain, Postoperative

Interventions

AmoxicillinClavulanic Acid

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic Acids

Study Officials

  • Ahmed Gomaa, Postgraduate

    Cairo University

    PRINCIPAL INVESTIGATOR

  • khaled Ezzat, Professor

    Cairo University

    STUDY CHAIR

  • Suzan AW Amin, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Gomaa, Postgraduate

CONTACT

01006610083ahmed.eltoukhy@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post-graduate candidate

Study Record Dates

First Submitted

December 19, 2016

First Posted

January 2, 2017

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Last Updated

January 2, 2017

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share