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Completed

NCT Number: NCT03262077

Dose Parameters for Photodynamic Therapy on Periodontal Disease

Due to the phenomenon of bacterial resistance, photodynamic therapy (PDT) has been studied as an alternative to the use of antibiotics on the periodontal treatment. However, the studies show several discrepancies between the parameters adopted for PDT, which makes it difficult to compare the results and measure their efficacy. The objective of this research was to investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal disease. In order to achieve this objective, the scattering pattern of light in periodontal tissue, the concentration of methylene blue in the periodontal pockets and the number of viable microorganisms were evaluated. This clinical trial included 30 patients with chronic periodontitis according to the eligibility criteria. The patients were in periodontal treatment at the Dental Clinic at the University of Nove de Julho, where the research was carried out. Three incisors from each patient were selected for the experimental procedures. The pattern of light scattering was observed through intraoral photographs. A laser with emission of radiation with wavelength of 660 nm and 100 mW of power was used. The concentration of the photosensitizer (PS) in the periodontal pockets was evaluated by spectrometer before irradiation. Methylene blue was used as PS at the concentration of 100 μM in two different formulation and vehicles to evaluate the drug dimerization. Then, the procedures of irradiation of the PDT were carried out, with 3 irradiation times of 1, 3 and 5 min. The microbiological evaluation was performed from subgengival biofilms of the periodontal pockets of the experimental sites, before and immediately after the irradiation procedures.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with chronic periodontitis;
  • The patient should have at least 15 teeth present, with a minimum of 3 incisors with depth of probing greater than 4 mm;
  • The patient should be in periodontal treatment at the Dental Clinic of the University of Nove de Julho, where this research was carried out. All patients were treated according to the protocol recommended by the American Academy of Periodontology;
  • Minimum age of 18 years.

Exclusion criteria

  • current smokers or regular smoking 12 months prior to enrollment;
  • patients with anemia,
  • patients with active cancer;
  • pregnant;
  • history of antibiotic therapy in the previous six months;
  • history of anti-inflammatory therapy in the previous three months;
  • patients with clotting disorders;
  • patients currently undergoing orthodontic treatment.

Treatment and study plan

Methylene Blue

Drug

Irradiation with low-level laser for 1, 3, and 5 min

Methylene Blue Oral Product

Drug

Irradiation with low-level laser for 1, 3, and 5 min

Primary outcomes

  1. Bacterial reduction

    Time frame: 48 hours after the laser irradiation procedure.

    Count of Colony Forming Units

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Collaborators

  • Sandra Kalil Bussadori

Registry information

Official study title

Evaluation of Parameters of Tissue Dosimetry in Photodynamic Therapy for the Treatment of Periodontal Disease - Clinical Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 25, 2017
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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