Dose Parameters for Photodynamic Therapy on Periodontal Disease

NCT03262077 | Completed

• 1 other identifier: University of Nove de Julho
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Keywords

photodynamic therapy; periodontal disease; dosimetry; methylene blue

Outcome Measures

Primary Outcomes (1)

• Bacterial reduction

  Count of Colony Forming Units

  48 hours after the laser irradiation procedure.

Study Arms (6)

MB 1 min

EXPERIMENTAL

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

MB 3 min

EXPERIMENTAL

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

MB 5 min

EXPERIMENTAL

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

MBS 1 min

EXPERIMENTAL

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

MBS 3 min

EXPERIMENTAL

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

MBS 5 min

EXPERIMENTAL

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

Interventions

Methylene Blue DRUG

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

MB 1 min; MB 3 min; MB 5 min

Methylene Blue Oral Product DRUG

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

MBS 1 min; MBS 3 min; MBS 5 min

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead
• Sandra Kalil Bussadori: collaborator

MeSH Terms

Conditions

Chronic Periodontitis; Periodontal Diseases

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Periodontitis; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD.

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: August 25, 2017
• Study Start: October 11, 2016
• Primary Completion: June 26, 2017
• Study Completion: June 26, 2017
• Last Updated: August 25, 2017

Record last verified: 2017-08