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Dose Parameters for Photodynamic Therapy on Periodontal Disease

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Methylene Blue
Methylene Blue Oral Product
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Periodontitis focused on measuring photodynamic therapy, periodontal disease, dosimetry, methylene blue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient with chronic periodontitis;
  • The patient should have at least 15 teeth present, with a minimum of 3 incisors with depth of probing greater than 4 mm;
  • The patient should be in periodontal treatment at the Dental Clinic of the University of Nove de Julho, where this research was carried out. All patients were treated according to the protocol recommended by the American Academy of Periodontology;
  • Minimum age of 18 years.

Exclusion Criteria:

  • current smokers or regular smoking 12 months prior to enrollment;
  • patients with anemia,
  • patients with active cancer;
  • pregnant;
  • history of antibiotic therapy in the previous six months;
  • history of anti-inflammatory therapy in the previous three months;
  • patients with clotting disorders;
  • patients currently undergoing orthodontic treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    MB 1 min

    MB 3 min

    MB 5 min

    MBS 1 min

    MBS 3 min

    MBS 5 min

    Arm Description

    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.

    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.

    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.

    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.

    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.

    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.

    Outcomes

    Primary Outcome Measures

    Bacterial reduction
    Count of Colony Forming Units

    Secondary Outcome Measures

    Full Information

    First Posted
    August 23, 2017
    Last Updated
    August 23, 2017
    Sponsor
    University of Nove de Julho
    Collaborators
    Sandra Kalil Bussadori
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03262077
    Brief Title
    Dose Parameters for Photodynamic Therapy on Periodontal Disease
    Official Title
    Evaluation of Parameters of Tissue Dosimetry in Photodynamic Therapy for the Treatment of Periodontal Disease - Clinical Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 11, 2016 (Actual)
    Primary Completion Date
    June 26, 2017 (Actual)
    Study Completion Date
    June 26, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho
    Collaborators
    Sandra Kalil Bussadori

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as an alternative to the use of antibiotics on the periodontal treatment. However, the studies show several discrepancies between the parameters adopted for PDT, which makes it difficult to compare the results and measure their efficacy. The objective of this research was to investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal disease. In order to achieve this objective, the scattering pattern of light in periodontal tissue, the concentration of methylene blue in the periodontal pockets and the number of viable microorganisms were evaluated. This clinical trial included 30 patients with chronic periodontitis according to the eligibility criteria. The patients were in periodontal treatment at the Dental Clinic at the University of Nove de Julho, where the research was carried out. Three incisors from each patient were selected for the experimental procedures. The pattern of light scattering was observed through intraoral photographs. A laser with emission of radiation with wavelength of 660 nm and 100 mW of power was used. The concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM in two different formulation and vehicles to evaluate the drug dimerization. Then, the procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5 min. The microbiological evaluation was performed from subgengival biofilms of the periodontal pockets of the experimental sites, before and immediately after the irradiation procedures.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Periodontitis
    Keywords
    photodynamic therapy, periodontal disease, dosimetry, methylene blue

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MB 1 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.
    Arm Title
    MB 3 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.
    Arm Title
    MB 5 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.
    Arm Title
    MBS 1 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.
    Arm Title
    MBS 3 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.
    Arm Title
    MBS 5 min
    Arm Type
    Experimental
    Arm Description
    Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.
    Intervention Type
    Drug
    Intervention Name(s)
    Methylene Blue
    Intervention Description
    Irradiation with low-level laser for 1, 3, and 5 min
    Intervention Type
    Drug
    Intervention Name(s)
    Methylene Blue Oral Product
    Intervention Description
    Irradiation with low-level laser for 1, 3, and 5 min
    Primary Outcome Measure Information:
    Title
    Bacterial reduction
    Description
    Count of Colony Forming Units
    Time Frame
    48 hours after the laser irradiation procedure.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patient with chronic periodontitis; The patient should have at least 15 teeth present, with a minimum of 3 incisors with depth of probing greater than 4 mm; The patient should be in periodontal treatment at the Dental Clinic of the University of Nove de Julho, where this research was carried out. All patients were treated according to the protocol recommended by the American Academy of Periodontology; Minimum age of 18 years. Exclusion Criteria: current smokers or regular smoking 12 months prior to enrollment; patients with anemia, patients with active cancer; pregnant; history of antibiotic therapy in the previous six months; history of anti-inflammatory therapy in the previous three months; patients with clotting disorders; patients currently undergoing orthodontic treatment.

    12. IPD Sharing Statement

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    Dose Parameters for Photodynamic Therapy on Periodontal Disease

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