Photodynamic Therapy (PDT) for Oral Disinfection

University of Sao Paulo

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Device: blue LED illumination; Drug: mouthwash with curcumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02152475

CNPQ2013

Details and patient eligibility

About

Photodynamic therapy (PDT) is a technique used for the oral disinfection. In dentistry, PDT for microbial inactivation may reduces both dental plaque and risk of developing caries as well as contributes to treat gingivitis, periodontitis, peri-implantitis and endodontic diseases. The investigators hypothesis was that PDT with blue light and curcumin promotes oral disinfection during 2 hours after treatment.

Full description

PDT uses a non-toxic drug that is activated by exposure to light in the presence of oxygen. The excited state this drug transfers energy or electrons to ground state molecular oxygen producing cytotoxic effects on cell. There are productions of reactive oxygen species (ROS) and disrupts several of the cell's functions. This results in bacterial disinfection. In order to perform the PDT on the oral cavity, a device based on blue LED with transparent acrylic diffuser tip and cylindrical shape was developed.

Enrollment: 30 patients

Sex: All

Ages: 20 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-users of any antibiotic therapy
• those who do not perform any oral hygiene, such as flossing, brushing and antiseptic mouthwash
• those who performed 12-hour fasting prior the treatment and measurements

Exclusion criteria

• oral cancer
• smoking habits
• pregnancy
• patients with partial or total dentures
• orthodontic brackets users

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

PDT with blue light and curcumin

Experimental group

Description:

PDT treatment was performed with light and curcumin.The irradiation parameters were: blue-light emitting diode (LED) illumination (455±30 nm), 400 mW of average optical power, 5 min of application, illumination area of 0.666 cm2, 600 mW/cm2 of intensity and 120 J/cm2 of fluence. The curcumin concentration of 30 mg/L was used.

Treatment:

Drug: mouthwash with curcumin

Device: blue LED illumination

Curcumin

Active Comparator group

Description:

The curcumin concentration of 30 mg/L was used.

Treatment:

Drug: mouthwash with curcumin

Blue light

Active Comparator group

Description:

The irradiation parameters were: blue-light emitting diode (LED) illumination (455±30 nm), 400 mW of average optical power, 5 min of application, illumination area of 0.666 cm2, 600 mW/cm2 of intensity and 120 J/cm2 of fluence.

Treatment:

Device: blue LED illumination