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An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin

Primary Purpose

Dental Caries

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Rubber dam isolation
Tooth drying
Dentin wash with chlorhexidine 2%
Antimicrobial Photodynamic Therapy 1
Antimicrobial Photodynamic Therapy 2
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Photochemotherapy, Bacteria

Eligibility Criteria

5 Years - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.

Exclusion Criteria:

  • Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Control

    APDT 1

    APDT 2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
    Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)

    Secondary Outcome Measures

    Tooth Pain
    Patients reported the presence or absence of tooth pain after 6 months
    Tooth Pain
    Patients reported the presence or absence of tooth pain after 6 months
    Restoration Quality
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months
    Restoration Quality
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months

    Full Information

    First Posted
    May 25, 2015
    Last Updated
    June 24, 2015
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02479958
    Brief Title
    An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
    Official Title
    A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Despite of the decline of dental caries, this disease is still common in polarized groups affecting children. Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Caries
    Keywords
    Photochemotherapy, Bacteria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    58 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    Experimental
    Arm Title
    APDT 1
    Arm Type
    Experimental
    Arm Title
    APDT 2
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    Rubber dam isolation
    Intervention Description
    Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
    Intervention Type
    Procedure
    Intervention Name(s)
    Tooth drying
    Intervention Description
    The tooth was dried with air jet.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dentin wash with chlorhexidine 2%
    Intervention Description
    Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with chlorhexidine 2%. After that a a new dentin collection was performed at another site of the cavity, and restoration with resin-modified glass ionomer cement was placed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Antimicrobial Photodynamic Therapy 1
    Intervention Description
    Partial carious tissue was removed with conventional dentine curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s. After this, a red LED light source with wavelength of 630 nm was used at 100 mW power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement Vitremer was placed.
    Intervention Type
    Procedure
    Intervention Name(s)
    Antimicrobial Photodynamic Therapy 2
    Intervention Description
    Partial carious tissue was removed with conventional dentine curette and initial collection of dentin with a micropunch (Ø = 1mm) was performed. Treatment of the remaining dentin was performed with 200 µL of methylene blue dye 0.01% for 5 min and after this, a red low level LASER light source with wavelength of 660 nm was used at 100 mW power, 9.0 J of energy, for 90 s with energy density of 320.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement was placed.
    Primary Outcome Measure Information:
    Title
    Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)
    Description
    Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)
    Time Frame
    15 days after dentin collection
    Secondary Outcome Measure Information:
    Title
    Tooth Pain
    Description
    Patients reported the presence or absence of tooth pain after 6 months
    Time Frame
    6 months
    Title
    Tooth Pain
    Description
    Patients reported the presence or absence of tooth pain after 6 months
    Time Frame
    12 months
    Title
    Restoration Quality
    Description
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 6 months
    Time Frame
    6 months
    Title
    Restoration Quality
    Description
    The quality of restoration was evaluated through the absence of radiographic radiolucent area after 12 months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    7 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits. Exclusion Criteria: Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

    12. IPD Sharing Statement

    Learn more about this trial

    An in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin

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