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Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.

Primary Purpose

Asymptomatic Necrotic Teeth

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
triple antibiotic paste with an anti-inflammatory drug
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asymptomatic Necrotic Teeth focused on measuring post operative pain, triple antibiotic paste, intracanal medication

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject's age between 18-50 years.
  2. Both male and female subjects.
  3. Medically free and healthy subjects.
  4. Mandibular and maxillary single rooted teeth.
  5. Asymptomatic non vital teeth.

Exclusion Criteria:

  1. Teeth with acute dentoalveolar abscess.
  2. Subjects having more than one tooth that require root canal treatment.
  3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
  4. Pregnant females.
  5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
  6. Teeth with periodontal disease or pulp calcification.
  7. Subjects taking chronic pain medications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Other

    Arm Label

    Control: Calcium Hydroxide

    Test: Triple Antibiotic Paste and Anti-Inflammatory Drug

    Arm Description

    Non-setting Calcium Hydroxide

    Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)

    Outcomes

    Primary Outcome Measures

    Post Operative Pain
    Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )

    Secondary Outcome Measures

    Intracanal Bacterial Count
    Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)

    Full Information

    First Posted
    September 8, 2016
    Last Updated
    September 21, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02907489
    Brief Title
    Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
    Official Title
    The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    April 2018 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.
    Detailed Description
    This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asymptomatic Necrotic Teeth
    Keywords
    post operative pain, triple antibiotic paste, intracanal medication

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control: Calcium Hydroxide
    Arm Type
    No Intervention
    Arm Description
    Non-setting Calcium Hydroxide
    Arm Title
    Test: Triple Antibiotic Paste and Anti-Inflammatory Drug
    Arm Type
    Other
    Arm Description
    Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
    Intervention Type
    Other
    Intervention Name(s)
    triple antibiotic paste with an anti-inflammatory drug
    Intervention Description
    Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
    Primary Outcome Measure Information:
    Title
    Post Operative Pain
    Description
    Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )
    Time Frame
    after 24, 48, and 72 hour from the end of the first visit.
    Secondary Outcome Measure Information:
    Title
    Intracanal Bacterial Count
    Description
    Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)
    Time Frame
    before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject's age between 18-50 years. Both male and female subjects. Medically free and healthy subjects. Mandibular and maxillary single rooted teeth. Asymptomatic non vital teeth. Exclusion Criteria: Teeth with acute dentoalveolar abscess. Subjects having more than one tooth that require root canal treatment. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment. Pregnant females. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance. Teeth with periodontal disease or pulp calcification. Subjects taking chronic pain medications.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    https://www.scribd.com/document/328018560/Protocol-Omaia-Repaired-Autosaved

    Learn more about this trial

    Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.

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