Dose Parameters for Photodynamic Therapy on Periodontal Disease

Chronic Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03262077
• Other study ID #: University of Nove de Julho
• Status: Completed
• Phase: N/A
• First received: August 23, 2017
• Last updated: August 23, 2017
• Start date: October 11, 2016
• Est. completion date: June 26, 2017

Study information

• Verified date: August 2017
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2017
• Est. primary completion date: June 26, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Periodontitis
• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Methylene Blue
Irradiation with low-level laser for 1, 3, and 5 min
• Methylene Blue Oral Product
Irradiation with low-level laser for 1, 3, and 5 min

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Sandra Kalil Bussadori

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial reduction	Count of Colony Forming Units	48 hours after the laser irradiation procedure.