NCT03033472

Brief Summary

The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin 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
72

participants targeted

Target at P50-P75 for phase_2

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

January 24, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

First QC Date

January 24, 2017

Last Update Submit

January 26, 2017

Conditions

Symptomatic Periapical Periodontitis

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)

Clindamycin

EXPERIMENTAL

600 mg of Clindamycin orally 30 minutes before root canal treatment

Drug: 600 mg Clindamycin orally

Placebo

PLACEBO COMPARATOR

placebo 30 minutes Orally before treatment

Drug: Oral Placebo

Interventions

600 mg Clindamycin orallyDRUG

600 mg Clindamycin orally 30 minutes before treatment

Clindamycin
Oral PlaceboDRUG

Oral Placebo 30 minutes before treatment

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
  • Mandibular posterior teeth.
  • Patients in good health.
  • Patients who can understand pain scales (NRS).
  • Patients able to sign informed consent.

You may not qualify if:

  • Patients who have draining sinus tract.
  • Retreatment cases
  • Patients with weeping canals.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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: 24967571RESULT

  • Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.

    PMID: 16343114RESULT

Study Officials

  • Nermeen SA El Sedawy, Post Graduate

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Suzan AW Wanees, PhD

    Cairo Univertsity

    STUDY CHAIR

  • Shaimaa Gawdat, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Nermeen SA El Sedawy, Post Graduate

CONTACT

01002463414nermeen.elsedaway@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Primary Completion

December 1, 2017

Last Updated

January 27, 2017

Record last verified: 2017-01