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Trial record 49 of 61 for:    Neomycin sulfate

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

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ClinicalTrials.gov Identifier: NCT03763110
Recruitment Status : Active, not recruiting
First Posted : December 4, 2018
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
ElShaimaa Abdelhafiz Abdelrahim, Cairo University

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:

  1. Clinical success in terms of absence of any complication such as spontaneous pain, sinus or swelling.
  2. Radiographic success in terms of healing of periapical radiolucency or increase root thickness, length or apical closure.

Condition or disease Intervention/treatment Phase
Pulp Necrosis Device: Photo Activated Disinfection Drug: antibiotic paste Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 15, 2016
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Photo Activated Disinfection
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
Device: Photo Activated Disinfection
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
Other Name: Photodynamic therapy (PDT)

Active Comparator: Antibiotic paste
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
Drug: antibiotic paste
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
Other Name: Triple antibiotic paste




Primary Outcome Measures :
  1. absence of postoperative pain [ Time Frame: immediate post operative ]
    binary question by asking patients (yes or no)

  2. absence of postoperative pain [ Time Frame: at 3 months follow up ]
    binary question by asking patients (yes or no)

  3. absence of postoperative pain [ Time Frame: at 6 months follow up ]
    binary question by asking patients (yes or no)

  4. absence of postoperative pain [ Time Frame: at 9 months follow up ]
    binary question by asking patients (yes or no)

  5. absence of postoperative pain [ Time Frame: at 12 months follow up ]
    binary question by asking patients (yes or no)


Secondary Outcome Measures :
  1. healing of sinus [ Time Frame: immediate post operative, 3 months, 6 months, 9 months, 12 months ]
    Clinical success in term of absence of sinus (Yes or No)

  2. healing of swelling [ Time Frame: immediate post operative, 3 months, 6 months, 9 months, 12 months ]
    Clinical success in term of absence of swelling (Yes or No)

  3. healing of periapical radiolucency [ Time Frame: baseline, 6 months, 12 months ]
    Radiographic success in term of healing of periapical or radiolucency (Yes or No)

  4. change in root length [ Time Frame: baseline, 6 months, 12 months ]
    Radiographic evaluation by calibration of root length in millimetre by Digora

  5. change in dentin root thickness [ Time Frame: baseline, 6 months, 12 months ]
    Radiographic evaluation by calibration of root thickness in millimetre by Digora

  6. change in apical diameter [ Time Frame: baseline, 6 months, 12 months ]
    Radiographic evaluation by calibration of apical diameter in millimetre by Digora



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: ElShaimaa Abdelhafiz Abdelrahim, assistant lecturer in paediatric dentistry department at Fayoum university, Cairo University
ClinicalTrials.gov Identifier: NCT03763110     History of Changes
Other Study ID Numbers: Regenerative endodontic
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
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Neomycin
Necrosis
Dental Pulp Necrosis
Pathologic Processes
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Bacitracin
Polymyxin B
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action