NCT03033147

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
2.7 years until next milestone

Study Start

First participant enrolled

October 18, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

5 months

First QC Date

January 24, 2017

Last Update Submit

June 15, 2021

Conditions

Symptomatic Periapical Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

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

    Up to 7 days after endodontic treatment

Secondary Outcomes (1)

  • Swelling

    Up to 7 days after endodontic treatment

Study Arms (2)

Amoxicillin/Clavulanate Potassium

EXPERIMENTAL

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

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

Placebo

PLACEBO COMPARATOR

placebo 30 minutes before root canal treatment

Drug: Oral placebo

Interventions

Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tabletDRUG

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

Also known as: Augmentin
Amoxicillin/Clavulanate Potassium
Oral placeboDRUG

placebo 30 minutes before root canal treatment

Placebo

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.
  • 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

Study Sites (1)

Cairo University Faculty of Dentistry

Cairo, Egypt

Location

Related Publications (4)

  • 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

  • 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.

    PMID: 25954695BACKGROUND

  • 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.

    PMID: 15920447BACKGROUND

  • 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.

    PMID: 11487166BACKGROUND

MeSH Terms

Interventions

AmoxicillinClavulanic AcidAmoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsClavulanic AcidsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Nermeen NT Moushtaha, Postgraduate

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Suzan AW Amin, PhD

    Cairo University

    STUDY CHAIR

  • Shaimaa Gawdat, PhD

    Cairo University

    STUDY DIRECTOR

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
Principal Investigator

Study Record Dates

First Submitted

January 24, 2017

First Posted

January 26, 2017

Study Start

October 18, 2019

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

June 18, 2021

Record last verified: 2021-06

Locations

EG(1)