Photodynamic Therapy (PDT) for Oral Disinfection

Healthy Clinical Trial

Official title:

PDT With Blue Light and Curcumin for Oral Disinfection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02152475
• Other study ID #: CNPQ2013
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2014
• Last updated: May 30, 2014
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• mouthwash with curcumin
Mouthwash with 20 ml of curcumin solution for 5 minutes

Device:
• blue LED illumination
Oral cavity was illuminated with blue light for 5 minutes

Locations

Country	Name	City	State
Brazil	Fernanda Rossi Paolillo	São Carlos	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

Araújo 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. — View Citation

Araújo 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. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Optics and Photonics Research Center