HealthyPhase 1NCT02152475
Photodynamic Therapy (PDT) for Oral Disinfection
A Phase 1 study testing mouthwash with curcumin and blue LED illumination in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mouthwash with curcumin and blue LED illumination
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Nov 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- oral cancer
- smoking habits
- pregnancy
- patients with partial or total dentures
- orthodontic brackets users
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- mouthwash with curcumin, blue LED illumination
- Keywords
- Blue-LED, Curcumin, PDT, Oral disinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouthwash with curcuminDrug
Mouthwash with 20 ml of curcumin solution for 5 minutes
blue LED illuminationDevice
Oral cavity was illuminated with blue light for 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: mouthwash with curcumin; Device: blue LED illumination |
| Curcumin | Active comparator | The curcumin concentration of 30 mg/L was used. Receives: 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. Receives: Device: blue LED illumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Fernanda Rossi Paolillo, University of Sao Paulo
- Investigators
- Vanderlei S Bagnato, Ph.D, Study director, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Diego PV Leite, DDS, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Fernanda R Paolillo, Ph.D, Principal investigator, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)Carla R Fontana, Ph.D, Principal investigator, Univ Estadual Paulista (UNESP)Thiago Parmesano, Student, Study chair, Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152475
- Sponsor's protocol ID
- CNPQ2013
- Status last verified
- May 2014
- First submitted
- 24 May 2014
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22224655Araujo 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.
PubMed 23793414Gursoy 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.
PubMed 23015026Fontana 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.
PubMed 22467011Soukos 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.
PubMed 15793117
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PDT With Blue Light and Curcumin for Oral Disinfection
- ClinicalTrials.gov ID
- NCT02152475
- Acronym / sponsor ID
- CNPQ2013
- Conditions
- Healthy
- Keywords
- Blue-LED, Curcumin, PDT, Oral disinfection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PDT with blue light and curcumin | Experimental | Drug: mouthwash with curcumin, Device: blue LED illuminationPDT 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. |
| Curcumin | Active comparator | Drug: mouthwash with curcuminThe curcumin concentration of 30 mg/L was used. |
| Blue light | Active comparator | Device: blue LED illuminationThe 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. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- oral cancer
- smoking habits
- pregnancy
- patients with partial or total dentures
- orthodontic brackets users
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouthwash with curcuminMouthwash with 20 ml of curcumin solution for 5 minutes | Drug | Curcumin, PDT with blue light and curcumin |
| blue LED illuminationOral cavity was illuminated with blue light for 5 minutes | Device | Blue light, PDT with blue light and curcumin |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
- Results publication: PubMed 22224655Araujo 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.
- Results publication: PubMed 23793414Araujo 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.
- Results publication: PubMed 23015026Gursoy 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.
- Results publication: PubMed 22467011Fontana 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.
- Results publication: PubMed 15793117Soukos 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.
- Optics and Photonics Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanderlei S Bagnato, Ph.D study director
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Diego PV Leite, DDS principal investigator
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
Fernanda R Paolillo, Ph.D principal investigator
Physics Institute of São Carlos (IFSC), University of São Paulo (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mouthwash with curcumin and blue LED illumination in people with Healthy, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological analysis by the total number of colony-forming units (CFU). (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02152475, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.