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Photodynamic Therapy (PDT) for Oral Disinfection

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ClinicalTrials.gov Identifier: NCT02152475
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Fernanda Rossi Paolillo, 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.

Condition or disease Intervention/treatment Phase
Healthy Drug: mouthwash with curcumin Device: blue LED illumination Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PDT With Blue Light and Curcumin for Oral Disinfection
Study Start Date : May 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: PDT with blue light and 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.
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

Active Comparator: Curcumin
The curcumin concentration of 30 mg/L was used.
Drug: mouthwash with curcumin
Mouthwash with 20 ml of curcumin solution for 5 minutes

Active Comparator: Blue light
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
Oral cavity was illuminated with blue light for 5 minutes




Primary Outcome Measures :
  1. Microbiological analysis by the total number of colony-forming units (CFU). [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02152475


Locations
Brazil
Fernanda Rossi Paolillo
São Carlos, São Paulo, Brazil, 970
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Study Director: Vanderlei S Bagnato, Ph.D Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Principal Investigator: 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)
Study Chair: Thiago Parmesano, Student Physics Institute of São Carlos (IFSC), University of São Paulo (USP)

Additional Information:
Publications of Results:
Responsible Party: Fernanda Rossi Paolillo, Ph.D, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02152475     History of Changes
Other Study ID Numbers: CNPQ2013
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014

Keywords provided by Fernanda Rossi Paolillo, University of Sao Paulo:
Blue-LED
Curcumin
PDT
Oral disinfection

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action