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Single Versus Multiple Visits Endodontic Treatment

Primary Purpose

Periapical Periodontitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
mixture of metronidazole, ciprofloxacin, and minocycline
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Periodontitis

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adult patients; age between 16-55 years old.
  2. Males or Females.

  3. Maxillary or mandibular single-root tooth or a multi-rooted tooth with:

    • Non-vital response of pulp tissue.
    • Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth.
    • Asymptomatic patients.
  4. Positive patients' acceptance for participation in the study.

Exclusion Criteria:

  1. Primary teeth, and permanent teeth with immature apex.
  2. Teeth previously accessed or endodontically treated.
  3. Patients with diabetes and immune-compromising disease.
  4. Patients allergic to metronidazole, ciprofloxacin, or minocycline.
  5. Vital cases or necrotic without periapical lesion.
  6. Pregnant women.
  7. Teeth with unfavorable conditions for rubber-dam application.
  8. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    multiple visit

    single visit

    Arm Description

    multiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline)

    single visit root canal treatment without any intra-canal medication

    Outcomes

    Primary Outcome Measures

    postoperative pain
    using numerical rating scale from 0-10
    postoperative pain
    using numerical rating scale from 0-10
    postoperative pain
    using numerical rating scale from 0-10
    postoperative pain
    using numerical rating scale from 0-10

    Secondary Outcome Measures

    Radiographic healing
    using digital radiography
    Radiographic healing
    using digital radiography
    Radiographic healing
    using digital radiography
    Radiographic healing
    using digital radiography

    Full Information

    First Posted
    October 26, 2016
    Last Updated
    July 10, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02947763
    Brief Title
    Single Versus Multiple Visits Endodontic Treatment
    Official Title
    Healing Rates After Single Versus Multiple Visits Endodontic Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    February 2018 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Healing rate after single visit or multiple visit endodontic treatment using triple paste intracanal medicament will be assessed both clinically and radio-graphically for follow-up period up to one year
    Detailed Description
    Patients with necrotic teeth with apical periodontitis will be selected according to the eligibility criteria and patients are then randomized to either single visit or multiple visit using triple paste intracanal medicament. Postoperative pain will then assessed using numerical rating scale after 1, 2, 3 and 7 days post-instrumentation. Radiographic healing will be assessed every 3 months up to one year.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periapical Periodontitis

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    multiple visit
    Arm Type
    Active Comparator
    Arm Description
    multiple visit root canal treatment with triple antibiotic paste intracanal medication (a mixture of metronidazole, ciprofloxacin, and minocycline)
    Arm Title
    single visit
    Arm Type
    No Intervention
    Arm Description
    single visit root canal treatment without any intra-canal medication
    Intervention Type
    Drug
    Intervention Name(s)
    mixture of metronidazole, ciprofloxacin, and minocycline
    Other Intervention Name(s)
    no other names
    Intervention Description
    placement of intracanal medication
    Primary Outcome Measure Information:
    Title
    postoperative pain
    Description
    using numerical rating scale from 0-10
    Time Frame
    24 hours
    Title
    postoperative pain
    Description
    using numerical rating scale from 0-10
    Time Frame
    48 hours
    Title
    postoperative pain
    Description
    using numerical rating scale from 0-10
    Time Frame
    72 hours
    Title
    postoperative pain
    Description
    using numerical rating scale from 0-10
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Radiographic healing
    Description
    using digital radiography
    Time Frame
    3 months
    Title
    Radiographic healing
    Description
    using digital radiography
    Time Frame
    6 months
    Title
    Radiographic healing
    Description
    using digital radiography
    Time Frame
    9 months
    Title
    Radiographic healing
    Description
    using digital radiography
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients; age between 16-55 years old. Males or Females. Maxillary or mandibular single-root tooth or a multi-rooted tooth with: Non-vital response of pulp tissue. Radiographic evidence of periapical lesions (minimum size 2.0 mm × 2.0 mm) related to one root in case of multi-rooted teeth. Asymptomatic patients. Positive patients' acceptance for participation in the study. Exclusion Criteria: Primary teeth, and permanent teeth with immature apex. Teeth previously accessed or endodontically treated. Patients with diabetes and immune-compromising disease. Patients allergic to metronidazole, ciprofloxacin, or minocycline. Vital cases or necrotic without periapical lesion. Pregnant women. Teeth with unfavorable conditions for rubber-dam application. Tooth associated with vertical root fracture, coronal perforation, calcification and external or internal root resorption.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32047601
    Citation
    AbdurRahman S, Abdel Aziz SM, Gawdat SI, AbdalSamad AM. Postoperative pain of patients with necrotic teeth with apical periodontitis following single visit endodontic treatment versus multiple visit endodontic treatment using triple antibiotic paste: a randomized clinical trial. F1000Res. 2019 Jul 26;8:1203. doi: 10.12688/f1000research.19936.1. eCollection 2019.
    Results Reference
    derived

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    Single Versus Multiple Visits Endodontic Treatment

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