Clinical trial NCT02152475: Photodynamic Therapy (PDT) for Oral Disinfection
Official title: PDT With Blue Light and Curcumin for Oral Disinfection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Blue-LED
Curcumin
PDT
Oral disinfection
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Microbiological analysis by the total number of colony-forming units (CFU).
timeFrame: Two hours
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Fernanda Rossi Paolillo
state: São Paulo
Study officials:
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Vanderlei S Bagnato, Ph.D
role: STUDY_DIRECTOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Diego PV Leite, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Fernanda R Paolillo, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ Estadual Paulista (UNESP)
name: Carla R Fontana, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
name: Thiago Parmesano, Student
role: STUDY_CHAIR
References:
citation: Araujo NC, Fontana CR, Gerbi ME, Bagnato VS. Overall-mouth disinfection by photodynamic therapy using curcumin. Photomed Laser Surg. 2012 Feb;30(2):96-101. doi: 10.1089/pho.2011.3053. Epub 2012 Jan 6.
citation: Araujo NC, Fontana CR, Bagnato VS, Gerbi ME. Photodynamic antimicrobial therapy of curcumin in biofilms and carious dentine. Lasers Med Sci. 2014 Mar;29(2):629-35. doi: 10.1007/s10103-013-1369-3. Epub 2013 Jun 23.
citation: Gursoy H, Ozcakir-Tomruk C, Tanalp J, Yilmaz S. Photodynamic therapy in dentistry: a literature review. Clin Oral Investig. 2013 May;17(4):1113-25. doi: 10.1007/s00784-012-0845-7. Epub 2012 Sep 27.
citation: Fontana CR, Lerman MA, Patel N, Grecco C, Costa CA, Amiji MM, Bagnato VS, Soukos NS. Safety assessment of oral photodynamic therapy in rats. Lasers Med Sci. 2013 Feb;28(2):479-86. doi: 10.1007/s10103-012-1091-6. Epub 2012 Mar 31.
citation: Soukos NS, Som S, Abernethy AD, Ruggiero K, Dunham J, Lee C, Doukas AG, Goodson JM. Phototargeting oral black-pigmented bacteria. Antimicrob Agents Chemother. 2005 Apr;49(4):1391-6. doi: 10.1128/AAC.49.4.1391-1396.2005.