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
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Radiation: Antimicrobial photodynamic therapy (aPDT)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Livia Antunes, PhD||55 22 firstname.lastname@example.org|
|Contact: Pamela Ornellas, DDs||55 22 email@example.com|
|Universidade Federal Fluminense||Recruiting|
|Nova Friburgo, Rio De Janeiro, Brazil, 28625650|
|Contact: Livia Antunes, PhD 55219871519191 firstname.lastname@example.org|
|Contact: Leonardo Antunes, PhD 5521988911919 email@example.com|
|Principal Investigator:||Livia Antunes, PHD||Universidade Federal Fluminense|