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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Universidade Federal Fluminense

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidade Federal Fluminense

Dates:
Date Received: September 1, 2016
Date Started: March 2016
Date Completion:
Last Updated: September 18, 2016
Last Verified: September 2016