Dose Parameters for Photodynamic Therapy on Periodontal Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Periodontitis
• Intervention / Treatment: Drug: Methylene Blue; Drug: Methylene Blue Oral Product

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MB 1 min; Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.	Drug: Methylene Blue; Irradiation with low-level laser for 1, 3, and 5 min
Experimental: MB 3 min; Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.	Drug: Methylene Blue; Irradiation with low-level laser for 1, 3, and 5 min
Experimental: MB 5 min; Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.	Drug: Methylene Blue; Irradiation with low-level laser for 1, 3, and 5 min
Experimental: MBS 1 min; Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.	Drug: Methylene Blue Oral Product; Irradiation with low-level laser for 1, 3, and 5 min
Experimental: MBS 3 min; Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.	Drug: Methylene Blue Oral Product; Irradiation with low-level laser for 1, 3, and 5 min
Experimental: MBS 5 min; Methylene blue photosensitizer 100 μM + soap was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.	Drug: Methylene Blue Oral Product; Irradiation with low-level laser for 1, 3, and 5 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial reduction	Count of Colony Forming Units	48 hours after the laser irradiation procedure.

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Collaborators: Sandra Kalil Bussadori

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2016
• Primary Completion (Actual): June 26, 2017
• Study Completion (Actual): June 26, 2017

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: periodontal disease; photodynamic therapy; methylene blue; dosimetry
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontitis; Periodontal Diseases; Chronic Periodontitis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: University of Nove de Julho

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No