Clinical trial NCT03855345: Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease
Official title: Antimicrobial Photodynamic Therapy Mediated by PapaMBlue® on Chronic Periodontal Disease - Randomized Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Periodontal Diseases
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The elimination of the pathogenic microorganisms of the periodontal pocket is one of the main points for success in periodontal treatment. The objective of this study is to investigate the clinical and antimicrobial effect of papain-mediated photodynamic therapy in the clinical treatment of periodontal disease. Twenty patients with chronic periodontitis will be selected. Patients will be divided randomly into two groups (n = 10), and the control group will receive conventional periodontal treatment and group II will receive conventional treatment and antimicrobial photodynamic therapy (aPDT). Conventional treatment will consist of oral hygiene guidance, with brushing technique instructions and recommendation of daily flossing. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for scraping and root planing. The aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The PapaMblue® photosensitizer will be deposited in the periodontal pockets with a syringe and a pre-irradiation time of 1 min will be adopted. Then, the laser emitting wavelength of 660 nm, with power of 100 mW, for 2 min, radiant exposure of 30 J/cm2 and power density of 250 mW/cm2 will be applied. Patients will undergo clinical evaluations before treatment (day 1) and 30, 60 and 90 days after the end of treatment. Microbiological evaluations will be made before and 30 days after treatment. The distribution of the data within each group and the homogeneity of the variances will be verified. With this information, the most appropriate statistical test for each evaluation will be used. The sample calculation is based on the literature and the significance level of 5% will be adopted.


Eligibility criteria: Inclusion Criteria:

* The patient must have chronic periodontitis (AAP, 2001);
* At least 10 present teeth, with at least 3 sites with clinical depth of probing greater than 4 mm;
* The patient must be in periodontal treatment at the Dental Clinic of Universidade Nove de Julho, institution where this research will be carried out;

Exclusion Criteria:

* Smokers or former smokers who discontinued the habit less than 12 months prior to selection;
* Uncontrolled diabetes;
* Anemia;
* Cancer;
* Pregnant women;
* Use of antibiotics in the last 6 months;
* Use of anti-inflammatory in the last 3 months;
* Coagulation disorder (use of anti-coagulant, presence of liver diseases, thrombocytopenia and immunosuppression);
* Patients under orthodontic treatment;
* Patients who maintain a biofilm index greater than 25%.

Primary outcomes:
measure: Change in probing depth
timeFrame: Baseline, 30, 60 and 90 days after treatment.
Secondary outcomes:
measure: Change in probing bleeding
timeFrame: Baseline, 30, 60 and 90 days after treatment.
measure: Change in loss of clinical insertion
timeFrame: Baseline, 30, 60 and 90 days after treatment.
measure: Change in plaque index
timeFrame: Baseline, 30, 60 and 90 days after treatment.
measure: Microbiological examination (change in CFUs (Colony Forming Units))
timeFrame: Baseline, 30, 60 and 90 days after treatment.
Other outcomes:
Locations:
Study officials:
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