Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct Treatment of Deep Carious Lesions in Children
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This project aims to evaluate the effect of antimicrobial photodynamic therapy (aPDT) in deep
      carious lesions. This study was approved by the Research Ethics Committee and was conducted
      on 53 patients between 3 and 12 years. Patients included in the study should have at least
      one primary molar or permanent with deep active caries and limited occlusal/proximal surfaces
      involving beyond the inner half of dentin. The investigators 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 an 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 were 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 was held with the drill at low rpm under cooling with sterile saline. The
      removal of decayed tissue will start with 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 an adhesive and composite resin system. To collect
      data for the first outcome the dentin samples were collected from 23 participants with the
      help of spoon sterile dentine in two stages: C1 after digging and C2 after aPDT. The
      microbiological analyzes will be conducted by counting 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 the feasibility of
      total microorganisms; CHROMagar candida to Candida genus; Mitis Salaviarius agar with the
      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%. For the second outcome, a randomized clinical trial was designed. Primary molars
      of 30 patients (mean age 6.15 years) with deep caries lesions without signs and symptoms of
      pulpal involvement were selected. A total of 64 teeth were randomly divided into groups G1
      (SCR, 32 teeth) and G2 (SCR + aPDT, 32 teeth) for treatment, restored with composite and
      evaluated after a week (T0), 6 months (T1), and 12 months (T2) according to the criteria of
      FDI. Groups were compared using the Rao-Scott chi-squared test and the logistic regression
      analysis for complex designs to ac- count for multiple observations per subject (alpha =
      0.05). All participants answered a questionaire to detect the impact on Oral Health-related
      quality of life(OHRQoL) before and 3 months after the treatment. Based on this project we
      prove the clinical efficacy of aPDT using 0.01% methylene blue as an adjunct in reducing
      microorganisms from the interior of deep carious lesions and we contributed to demonstrate
      the clinical and radiographic success in a follow-up from 12 months providing additional
      support aPDT used as an adjunct to SCR on the longevity of composite resin restorations in
      primary molars. A low laser therapy (aPDT) with SCR did not influence negatively OHRQoL. In
      the practice of pediatric dentistry, this conservative dental treatment improved the OHRQoL
      after 3 months of follow up.
    


Intervention name(s): Antimicrobial photodynamic therapy (aPDT); Without Antimicrobial phothodynamic therapy
Intervention type(s): Radiation; Other
Intervention description(s): Selective caries removal + 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 + tooth restauration; Selective caries removal + tooth restauration
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Photochemotherapy