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Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth

Primary Purpose

Pulp Necrosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Photo Activated Disinfection
antibiotic paste
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis

Eligibility Criteria

8 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy children with no physical, mental or systemic conditions.
  • Developmental age of the child is the most important factor so periapical x- ray will be taken first to assure apex immaturity.
  • No sex predilection.
  • Restorable necrotic young permanent anterior teeth

Exclusion Criteria:

  • Root fracture.
  • Internal or external root resorption.
  • Parents or guardians refuse to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Photo Activated Disinfection

    Antibiotic paste

    Arm Description

    Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane

    Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation

    Outcomes

    Primary Outcome Measures

    absence of postoperative pain
    binary question by asking patients (yes or no)
    absence of postoperative pain
    binary question by asking patients (yes or no)
    absence of postoperative pain
    binary question by asking patients (yes or no)
    absence of postoperative pain
    binary question by asking patients (yes or no)
    absence of postoperative pain
    binary question by asking patients (yes or no)

    Secondary Outcome Measures

    healing of sinus
    Clinical success in term of absence of sinus (Yes or No)
    healing of swelling
    Clinical success in term of absence of swelling (Yes or No)
    healing of periapical radiolucency
    Radiographic success in term of healing of periapical or radiolucency (Yes or No)
    change in root length
    Radiographic evaluation by calibration of root length in millimetre by Digora
    change in dentin root thickness
    Radiographic evaluation by calibration of root thickness in millimetre by Digora
    change in apical diameter
    Radiographic evaluation by calibration of apical diameter in millimetre by Digora

    Full Information

    First Posted
    November 17, 2018
    Last Updated
    December 4, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03763110
    Brief Title
    Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
    Official Title
    Evaluation of Post-Operative Pain After Regenerative Endodontic Using Photo-Activated Oral Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 15, 2016 (Actual)
    Primary Completion Date
    December 15, 2018 (Anticipated)
    Study Completion Date
    April 15, 2019 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study aims to compare regenerative endodontics for necrotic young permanent anterior teeth using oral photo-activated disinfection versus triple antibiotic paste in terms of: Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling. Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.
    Detailed Description
    Disinfection of the root canal system is thought to be critical to the success of Regenerative Endodontic Procedures (REPs) as infection prevents regeneration, repair and stem cell activity . A suitable material for using as intra-canal medicament seems to be antibiotic. Triple antibiotic paste (TAP) containing metronidazole, ciprofloxacin and minocycline has been reported to be a successful regimen in controlling the root canal pathogen and in managing necrotic young permanent tooth . Recently, new disinfection methods have been developed to overcome the limitations of conventional disinfecting protocols that they may neither reduce the number of bacteria to a satisfactory level nor minimize the toxicity to periapical stem/progenitors . Other concerns regarding the use of TAP are tooth discoloration after treatment and bacterial resistance. Photo-activated oral disinfection is a novel disinfection method which present a great solution for the problem associated with triple antibiotic paste

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necrosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Photo Activated Disinfection
    Arm Type
    Experimental
    Arm Description
    Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
    Arm Title
    Antibiotic paste
    Arm Type
    Active Comparator
    Arm Description
    Hoshino et al. recommended a ratio of 1:1:1 of metronidazole (500 mg), minocycline (100 mg) and ciprofloxacin (200 mg) for the 3Mix formulation
    Intervention Type
    Device
    Intervention Name(s)
    Photo Activated Disinfection
    Other Intervention Name(s)
    Photodynamic therapy (PDT)
    Intervention Description
    Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
    Intervention Type
    Drug
    Intervention Name(s)
    antibiotic paste
    Other Intervention Name(s)
    Triple antibiotic paste
    Intervention Description
    An antibiotic mixture composed of ciprofloxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or "3mix", has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996
    Primary Outcome Measure Information:
    Title
    absence of postoperative pain
    Description
    binary question by asking patients (yes or no)
    Time Frame
    immediate post operative
    Title
    absence of postoperative pain
    Description
    binary question by asking patients (yes or no)
    Time Frame
    at 3 months follow up
    Title
    absence of postoperative pain
    Description
    binary question by asking patients (yes or no)
    Time Frame
    at 6 months follow up
    Title
    absence of postoperative pain
    Description
    binary question by asking patients (yes or no)
    Time Frame
    at 9 months follow up
    Title
    absence of postoperative pain
    Description
    binary question by asking patients (yes or no)
    Time Frame
    at 12 months follow up
    Secondary Outcome Measure Information:
    Title
    healing of sinus
    Description
    Clinical success in term of absence of sinus (Yes or No)
    Time Frame
    immediate post operative, 3 months, 6 months, 9 months, 12 months
    Title
    healing of swelling
    Description
    Clinical success in term of absence of swelling (Yes or No)
    Time Frame
    immediate post operative, 3 months, 6 months, 9 months, 12 months
    Title
    healing of periapical radiolucency
    Description
    Radiographic success in term of healing of periapical or radiolucency (Yes or No)
    Time Frame
    baseline, 6 months, 12 months
    Title
    change in root length
    Description
    Radiographic evaluation by calibration of root length in millimetre by Digora
    Time Frame
    baseline, 6 months, 12 months
    Title
    change in dentin root thickness
    Description
    Radiographic evaluation by calibration of root thickness in millimetre by Digora
    Time Frame
    baseline, 6 months, 12 months
    Title
    change in apical diameter
    Description
    Radiographic evaluation by calibration of apical diameter in millimetre by Digora
    Time Frame
    baseline, 6 months, 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    13 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy children with no physical, mental or systemic conditions. Developmental age of the child is the most important factor so periapical x- ray will be taken first to assure apex immaturity. No sex predilection. Restorable necrotic young permanent anterior teeth Exclusion Criteria: Root fracture. Internal or external root resorption. Parents or guardians refuse to participate in the study.

    12. IPD Sharing Statement

    Learn more about this trial

    Photo-Activated Disinfection Versus Triple-Antibiotic Paste for Management of Necrotic Young Permanent Anterior Teeth

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