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Trial record 24 of 1201 for:    tooth decay

Evaluation of Antimicrobial Photodynamic Therapy for the Treatment of Deep Carious Lesions in Children: an in Vivo Study

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ClinicalTrials.gov Identifier: NCT02908789
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Livia Azeredo Alves Antunes, Universidade Federal Fluminense

Brief Summary:
This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep carious lesions. This is an in vivo study approved at the Research Ethics Committee, which will be conducted in 30 patients between 3 and 12 years. Patients included in the study should have at least one primary molar or permanent with deep active caries limited occlusal / proximal surfaces involving beyond the inner half of dentin. The investigators will considered from exclusion criteria children whose parents refuse to sign the informed consent document; children who do not cooperate with the clinical examination/treatment; children with syndromes or chronic systemic diseases; teeth with painful symptoms consistent with irreversible pulpitis or mobility; periodontal changes; roots with pathological resorption; cases of primary teeth roots in advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning. The treatments will be carried out after local anesthesia and isolation of the operative field with a rubber dam. The removal of carious dentin surface demineralized necrotic and not subject to remineralization will be held with drill at low rpm under cooling with sterile saline. The removal of decayed tissue will start by the side walls and later on the pulp wall. After this time the intervention with aPDT using 0.01% methylene blue as photosensitizer will be held. Finally, the cavity is restored with adhesive and composite resin system. The dentin samples will be collected with the help of spoon sterile dentine in two stages: C1 after digging and C2 after aPDT. The microbiological analyzes will be conducted with counting of colony forming units (CFU / mg of carious dentin), blindly from coded samples. The viability of microorganisms will be evaluated in the following culture media: Brain Heart Infusion agar for feasibility total microorganisms; CHROMagar candida to Candida genus; Mitis Salaviarius agar with addition of bacitracin 0.2 U/mL, sucrose and glucose to Streptococcus mutans; Mitis Salivarius agar to total Streptococcus; Rogosa Agar to Lactobacillus spp. and enterococcosel for Enterococcus genus. The reproducibility of the counting method will be verified between triplicates. Microbiological data will be evaluated with appropriate statistical tests with a level of 5%. Based on this project is expected to prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing of microorganisms from interior of deep carious lesions contributing to the clinical and radiographic success in a follow up from 36 months.

Condition or disease Intervention/treatment Phase
Dental Caries Radiation: Antimicrobial photodynamic therapy (aPDT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Antimicrobial Photodynamic Therapy for the Treatment of Deep Carious Lesions in Children: an in Vivo Study
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Antimicrobial photodynamic therapy (aPDT)
The technique consists of a basic protocol of two steps: the use of a photosensitizer and the laser application. In the first step, the cavity was dried and then 0.01% methylene blue solution (Formula & Ação, São Paulo, Brazil) was applied to the entire cavity using a carpule in order to keep in contact with all the walls. It remained in the cavity for a pre-irradiation period of 5 minutes. In the second step, the excess of 0.01% methylene blue solution was removed and the cavity was irradiated with an Indium Gallium Aluminum Phosphorus diode laser (InGaAlP) (Laser DUO®, MM Optics, São Carlos, São Paulo, Brazil) with a wavelength of 660 nm (visible red), a spot area of 3mm2, and fixed output power of 100 mW. We adopted the following parameters: energy of 9 J with 90 seconds of exposure time. The irradiation was applied in continuous mode and the laser array was positioned, in contact, directly over the central part of the cavity.
Radiation: Antimicrobial photodynamic therapy (aPDT)
Antimicrobial photodynamic therapy (aPDT) is an effective low potency laser that involves the activation of a photosensitizer( 0.01% methylene blue ) by a visible light source that creates chemical reactions, producing cytotoxic reactive oxygen species and causing oxidative stress and inactivation of pathogenic microorganisms.




Primary Outcome Measures :
  1. Evaluate Antimicrobial photodynamic therapy (aPDT) on microorganism reduction in deep cavities immediately after dental caries remotion and immediately use aPDT [ Time Frame: Microorganisms reduction couting of colony forming units will be evaluated seven days after. The clinical success will be evaluated 3 months, 6 months, 12 months and 24 months. ]
    Microorganisms reduction count after after manual excavation (control) and immediately after aPDT (experimental) obtained by means counting of colony forming units (CFU / mg of carious dentin), blindly from coded samples from the following viability of microorganisms total microorganisms; Candida genus; Streptococcus mutans; total Streptococcus; Lactobacillus spp. and for Enterococcus genus.After the period of 3, 6, 12 and 24 months of implementation of the treatment, there will be clinical and radiographic examination for treatment success.



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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients included in the study should have at least one primary molar or permanent with deep active caries limited occlusal / proximal surfaces involving beyond the inner half of dentin.

Exclusion Criteria:

  • Children whose parents refuse to sign the informed consent document
  • Children who do not cooperate with the clinical examination/treatment
  • Children with syndromes or chronic systemic diseases
  • Teeth with painful symptoms consistent with irreversible pulpitis or mobility
  • Periodontal changes
  • Roots with pathological resorption
  • Cases of primary teeth roots in advanced stage of physiological resorption and patients that have made the use of any antibiotics during the study period or within three months prior to its beginning

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908789


Contacts
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Contact: Livia Antunes, PhD 55 22 25287166 liviaazeredo@gmail.com
Contact: Pamela Ornellas, DDs 55 22 25287166 pamelaornellas@hotmail.com

Locations
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Brazil
Universidade Federal Fluminense Recruiting
Nova Friburgo, Rio De Janeiro, Brazil, 28625650
Contact: Livia Antunes, PhD    55219871519191    liviaazeredo@gmail.com   
Contact: Leonardo Antunes, PhD    5521988911919    leonardoantunes@id.uff.br   
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
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Principal Investigator: Livia Antunes, PHD Universidade Federal Fluminense

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Responsible Party: Livia Azeredo Alves Antunes, Professor Lívia Azeredo Alves Antunes, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT02908789     History of Changes
Other Study ID Numbers: PDTa and dental carie
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Livia Azeredo Alves Antunes, Universidade Federal Fluminense:
Photochemotherapy

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action