Clinical trial NCT03262077: Dose Parameters for Photodynamic Therapy on Periodontal Disease
Official title: Evaluation of Parameters of Tissue Dosimetry in Photodynamic Therapy for the Treatment of Periodontal Disease - Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Keywords: photodynamic therapy
periodontal disease
dosimetry
methylene blue
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
Collaborators: name: Sandra Kalil Bussadori
First posted: 2017-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bacterial reduction
timeFrame: 48 hours after the laser irradiation procedure.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: