Photodynamic Therapy (PDT) for Oral Disinfection

NCT02152475 | Completed Phase 1 DMC

• 1 other identifier: CNPQ2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Blue-LED; Curcumin; PDT; Oral disinfection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

PDT with blue light and curcumin

EXPERIMENTAL

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; Device: blue LED illumination

Curcumin

ACTIVE COMPARATOR

The curcumin concentration of 30 mg/L was used.

Drug: mouthwash with curcumin

Blue light

ACTIVE COMPARATOR

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

Interventions

mouthwash with curcumin DRUG

Mouthwash with 20 ml of curcumin solution for 5 minutes

Curcumin; PDT with blue light and curcumin

blue LED illumination DEVICE

Oral cavity was illuminated with blue light for 5 minutes

Blue light; PDT with blue light and curcumin

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Fernanda Rossi Paolillo

São Carlos, São Paulo, 970, Brazil

Location

Related Publications (5)

• 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.

  PMID: 22224655 RESULT

• 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.

  PMID: 23793414 RESULT

• 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.

  PMID: 23015026 RESULT

• 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.

  PMID: 22467011 RESULT

• 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.

  PMID: 15793117 RESULT

Related Links

• Optics and Photonics Research Center

MeSH Terms

Interventions

Mouthwashes; Curcumin

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Vanderlei S Bagnato, Ph.D

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  STUDY DIRECTOR

• Diego PV Leite, DDS

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  PRINCIPAL INVESTIGATOR

• Fernanda R Paolillo, Ph.D

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  PRINCIPAL INVESTIGATOR

• Carla R Fontana, Ph.D

  Univ Estadual Paulista (UNESP)

  PRINCIPAL INVESTIGATOR

• Thiago Parmesano, Student

  Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D

Study Record Dates

• First Submitted: May 24, 2014
• First Posted: June 2, 2014
• Study Start: May 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-05

Locations

BR (1)