Photodynamic Therapy (PDT) for Oral Disinfection

NCT ID: NCT02152475

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

mouthwash with curcumin

Intervention Type DRUG

Mouthwash with 20 ml of curcumin solution for 5 minutes

blue LED illumination

Intervention Type DEVICE

Oral cavity was illuminated with blue light for 5 minutes

Curcumin

The curcumin concentration of 30 mg/L was used.

Group Type ACTIVE_COMPARATOR

mouthwash with curcumin

Intervention Type DRUG

Mouthwash with 20 ml of curcumin solution for 5 minutes

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.

Group Type ACTIVE_COMPARATOR

blue LED illumination

Intervention Type DEVICE

Oral cavity was illuminated with blue light for 5 minutes

Interventions

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mouthwash with curcumin

Mouthwash with 20 ml of curcumin solution for 5 minutes

Intervention Type DRUG

blue LED illumination

Oral cavity was illuminated with blue light for 5 minutes

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Fernanda Rossi Paolillo

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanderlei S Bagnato, Ph.D

Role: STUDY_DIRECTOR

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

Diego PV Leite, DDS

Role: PRINCIPAL_INVESTIGATOR

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

Fernanda R Paolillo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Carla R Fontana, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Univ Estadual Paulista (UNESP)

Thiago Parmesano, Student

Role: STUDY_CHAIR

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

Locations

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Fernanda Rossi Paolillo

São Carlos, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 22224655 (View on PubMed)

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.

Reference Type RESULT
PMID: 23793414 (View on PubMed)

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.

Reference Type RESULT
PMID: 23015026 (View on PubMed)

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.

Reference Type RESULT
PMID: 22467011 (View on PubMed)

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.

Reference Type RESULT
PMID: 15793117 (View on PubMed)

Related Links

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http://cepof.ifsc.usp.br/

Optics and Photonics Research Center

Other Identifiers

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CNPQ2013

Identifier Type: -

Identifier Source: org_study_id

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