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Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Primary Purpose

Symptomatic Periapical Periodontitis

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
600 mg Clindamycin orally
Oral Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

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

Exclusion Criteria:

  1. Patients who have draining sinus tract.
  2. Retreatment cases
  3. Patients with weeping canals.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Clindamycin

    Placebo

    Arm Description

    600 mg of Clindamycin orally 30 minutes before root canal treatment

    placebo 30 minutes Orally before treatment

    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

    First Posted
    January 24, 2017
    Last Updated
    January 26, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03033472
    Brief Title
    Effect of Preoperative Clindamycin on Postoperative Endodontic Pain
    Official Title
    Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (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

    5. Study Description

    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.
    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. Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed. 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
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Clindamycin
    Arm Type
    Experimental
    Arm Description
    600 mg of Clindamycin orally 30 minutes before root canal treatment
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    placebo 30 minutes Orally before treatment
    Intervention Type
    Drug
    Intervention Name(s)
    600 mg Clindamycin orally
    Intervention Description
    600 mg Clindamycin orally 30 minutes before treatment
    Intervention Type
    Drug
    Intervention Name(s)
    Oral Placebo
    Intervention Description
    Oral Placebo 30 minutes before treatment
    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
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: Patients who have draining sinus tract. Retreatment cases Patients with weeping canals.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nermeen SA El Sedawy, Post Graduate
    Phone
    01002463414
    Email
    nermeen.elsedaway@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nermeen SA El Sedawy, Post Graduate
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Suzan AW Wanees, PhD
    Organizational Affiliation
    Cairo Univertsity
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Shaimaa Gawdat, PhD
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Director

    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
    result
    PubMed Identifier
    16343114
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

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