Photodynamic Therapy (PDT) for Oral Disinfection

May 30, 2014 updated by: Fernanda Rossi Paolillo, University of Sao Paulo

PDT With Blue Light and Curcumin for Oral Disinfection

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • São Carlos, São Paulo, Brazil, 970
        • Fernanda Rossi Paolillo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

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).
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.
Two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Diego PV Leite, DDS, 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)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 24, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimate)

June 2, 2014

Study Record Updates

Last Update Posted (Estimate)

June 3, 2014

Last Update Submitted That Met QC Criteria

May 30, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNPQ2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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