Photodynamic Therapy (PDT) for Oral Disinfection

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: mouthwash with curcumin; Device: blue LED illumination

• Registration Number: NCT02152475
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-05
• Study First Submitted: 2014-05-24
• Study First Submitted QC: 2014-05-28
• Last Update Submitted: 2014-05-30
• Study First Posted: 2014-06-02
• Last Update Posted: 2014-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Curcumin	mouthwash with curcumin	The curcumin concentration of 30 mg/L was used.
PDT with blue light and curcumin	mouthwash with curcumin	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.
Blue light	blue LED illumination	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.
PDT with blue light and curcumin	blue LED illumination	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.

Primary Outcome Measures

Name	Time	Method
Microbiological analysis by the total number of colony-forming units (CFU).	Two hours	Two saliva samples from each volunteer were collected. The saliva samples underwent serial dilutions and 100-microliters aliquots were plated on brain heart infusion agar plates (in duplicate) and then incubated under microaerophilic conditions. After incubation, the total number of colony-forming units (CFU) was determined.

Trial Locations

Locations (1)

Fernanda Rossi Paolillo; 🇧🇷 São Carlos, São Paulo, Brazil