NCT02337192

Brief Summary

We demonstrated the use of the Antimicrobial Photodynamic Therapy as a coadjutant oral decontamination agent. It was also shown that SDS surfactant improves the antibacterial action of APDT when using Curcumin as the photosensitizer. The decontamination levels obtained with APDT are comparable with the levels observed with the use of Chlorhexidine. The clinical relevancy is the control of oral microbial load which will improve the patients' quality of life and will decrease the possibility of cross contamination in the dental office.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 13, 2015

Completed
Last Updated

January 13, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

December 4, 2014

Last Update Submit

January 8, 2015

Conditions

Keywords

Orthodontic, Photochemoterapy

Outcome Measures

Primary Outcomes (1)

  • Microbiological analysis by the total number of colony-forming units (CFU)

    one section ( one hour)

Study Arms (7)

Group 1

EXPERIMENTAL

Negative control - Moutwash with 1,5mL of dimethyl sulfoxide at 5% (DMSO) in water solution - During 2 minutes.

Drug: DMSO + water

Group 2

EXPERIMENTAL

Mouthwash with Swish with Curcumin

Drug: Curcumin

Group 3

EXPERIMENTAL

Moutwash with Swish with Curcumin + SDS

Drug: CurcuminDrug: Surfactant

Group 4

EXPERIMENTAL

Experiment use dental irradiation with blue light (LED) only.

Device: LED

Group 5

EXPERIMENTAL

Antimicrobial Photodynamic Therapy (APDT) with blue light and Curcumin salt.

Drug: CurcuminDevice: LED

Group 6

EXPERIMENTAL

Antimicrobial Photodynamic Therapy (APDT) with blue light, Curcumin salt and surfactant.

Drug: CurcuminDevice: LEDDrug: Surfactant

Group 7

EXPERIMENTAL

Positive control - Use of mouthwash with Chlorhexidine only

Drug: Chlorhexidine gluconate

Interventions

Also known as: Curcumin salt
Group 2Group 3Group 5Group 6
LEDDEVICE
Group 4Group 5Group 6
Group 3Group 6
Group 1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vitor Hugo Panhóca

São Carlos, São Paulo, 13560-970, Brazil

Location

Related Publications (1)

  • Iliadi A, Baumgartner S, Athanasiou AE, Eliades T, Eliades G. Effect of intraoral aging on the setting status of resin composite and glass ionomer orthodontic adhesives. Am J Orthod Dentofacial Orthop. 2014 Apr;145(4):425-33. doi: 10.1016/j.ajodo.2013.11.020.

MeSH Terms

Interventions

CurcuminTBP1901Surface-Active AgentsDimethyl SulfoxideWaterchlorhexidine gluconate

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicSpecialty Uses of ChemicalsChemical Actions and UsesSulfoxidesSulfur CompoundsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Vitor H Panhóca, Ms

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

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
Vitor Hugo Panhóca

Study Record Dates

First Submitted

December 4, 2014

First Posted

January 13, 2015

Study Start

January 1, 2014

Primary Completion

June 1, 2014

Study Completion

December 1, 2014

Last Updated

January 13, 2015

Record last verified: 2015-01

Locations