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More info
You can access this
clinical trial
if you have
Dental Caries
and you are
between 3 and 12
years old
The phase for this study is not defined.
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The purpose

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.

Provided treatments

  • Radiation: Antimicrobial photodynamic therapy (aPDT)

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02908789. The sponsor of the trial is Universidade Federal Fluminense and it is looking for 30 volunteers for the current phase.
Official trial title:
Evaluation of Antimicrobial Photodynamic Therapy for the Treatment of Deep Carious Lesions in Children: an in Vivo Study