Photodynamic Therapy (PDT) for Oral Disinfection

Study Overview
=================
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.

Official Title
-----------------
PDT With Blue Light and Curcumin for Oral Disinfection

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: mouthwash with curcumin
* Device: blue LED illumination


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDT with blue light and curcumin<br>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. | Drug: mouthwash with curcumin<br>* Mouthwash with 20 ml of curcumin solution for 5 minutes<br>Device: blue LED illumination<br>* Oral cavity was illuminated with blue light for 5 minutes<br>|
| Active Comparator: Curcumin<br>The curcumin concentration of 30 mg/L was used. | Drug: mouthwash with curcumin<br>* Mouthwash with 20 ml of curcumin solution for 5 minutes<br>|
| Active Comparator: Blue light<br>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. | Device: blue LED illumination<br>* Oral cavity was illuminated with blue light for 5 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiological analysis by the total number of colony-forming units (CFU). | 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. | Two hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blue-LED, Curcumin, PDT, Oral disinfection