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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03763110
Collaborator
(none)
40
2
30

Study Details

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:

  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
  • Device: Photo Activated Disinfection
  • Drug: antibiotic paste
N/A

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

Study Design

Study Type:
Interventional
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 :
Oct 15, 2016
Anticipated Primary Completion Date :
Dec 15, 2018
Anticipated Study Completion Date :
Apr 15, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • Triple antibiotic paste
  • Outcome Measures

    Primary Outcome Measures

    1. absence of postoperative pain [immediate post operative]

      binary question by asking patients (yes or no)

    2. absence of postoperative pain [at 3 months follow up]

      binary question by asking patients (yes or no)

    3. absence of postoperative pain [at 6 months follow up]

      binary question by asking patients (yes or no)

    4. absence of postoperative pain [at 9 months follow up]

      binary question by asking patients (yes or no)

    5. absence of postoperative pain [at 12 months follow up]

      binary question by asking patients (yes or no)

    Secondary Outcome Measures

    1. healing of sinus [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 [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 [baseline, 6 months, 12 months]

      Radiographic success in term of healing of periapical or radiolucency (Yes or No)

    4. change in root length [baseline, 6 months, 12 months]

      Radiographic evaluation by calibration of root length in millimetre by Digora

    5. change in dentin root thickness [baseline, 6 months, 12 months]

      Radiographic evaluation by calibration of root thickness in millimetre by Digora

    6. change in apical diameter [baseline, 6 months, 12 months]

      Radiographic evaluation by calibration of apical diameter in millimetre by Digora

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ElShaimaa Abdelhafiz Abdelrahim, assistant lecturer in paediatric dentistry department at Fayoum university, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03763110
    Other Study ID Numbers:
    • Regenerative endodontic
    First Posted:
    Dec 4, 2018
    Last Update Posted:
    Dec 5, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 5, 2018