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Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.

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ClinicalTrials.gov Identifier: NCT02337192
Recruitment Status : Completed
First Posted : January 13, 2015
Last Update Posted : January 13, 2015
Sponsor:
Information provided by (Responsible Party):
Fernanda Rossi Paolillo, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Dentist-Patient Relations Drug: Curcumin Device: LED Drug: Surfactant Drug: DMSO + water Drug: Chlorhexidine gluconate Phase 1

Detailed Description:
The installation of the orthodontic appliances promotes an increase in the retentive area available for microbial aggregation, difficult the oral health promotion and, in addition, promotes the artificial selection of biofilms containing a higher load of pathogenic microorganisms. In this way, it becomes of critical importance, the development of techniques that might aid in the reduction of the oral microbial load. One possible approach is the use of the Antimicrobial Photodynamic Therapy (APDT). In this direction, the objective of this study was to assess the clinical utility of the APDT and the association of the APDT with the SDS surfactant as oral decontamination agents in orthodontic patients. The selected patients (n=24) were randomly distributed within seven experimental groups: G1 - Negative control, G2 - Curcumin mouthwash, G3 - Curcumin mouthwash+SDS, G4 - light irradiation, G5 - APDT, G6 - APDT+SDS and G7 - Positive Control (Chlorhexidine mouthwash). Nonstimulated saliva samples were collected from each one of the patients in three steps (S), as follows: S1- Initial condition, S2 - Treatment with mouthwashes (water, Chlorhexidine or Curcumin) and S3 - After APDT treatment. The efficacy of the proposed treatment protocols was assessed in function of the survival fraction observed in each group. The obtained results were statistically analyzed using variance analysis (ANOVA) and the Kruskal-Wallis test.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Decontamination Using Antimicrobial Photodynamic Therapy Applied in Orthodontic Patients.
Study Start Date : January 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Experimental: Group 1
Negative control - Moutwash with 1,5mL of dimethyl sulfoxide at 5% (DMSO) in water solution - During 2 minutes.
Drug: DMSO + water
Experimental: Group 2
Mouthwash with Swish with Curcumin
Drug: Curcumin
Other Name: Curcumin salt

Experimental: Group 3
Moutwash with Swish with Curcumin + SDS
Drug: Curcumin
Other Name: Curcumin salt

Drug: Surfactant
Experimental: Group 4
Experiment use dental irradiation with blue light (LED) only.
Device: LED
Experimental: Group 5
Antimicrobial Photodynamic Therapy (APDT) with blue light and Curcumin salt.
Drug: Curcumin
Other Name: Curcumin salt

Device: LED
Experimental: Group 6
Antimicrobial Photodynamic Therapy (APDT) with blue light, Curcumin salt and surfactant.
Drug: Curcumin
Other Name: Curcumin salt

Device: LED
Drug: Surfactant
Experimental: Group 7
Positive control - Use of mouthwash with Chlorhexidine only
Drug: Chlorhexidine gluconate



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


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria were: being under fixed orthodontic treatment, absence of clinical signs of periodontal disease, not used antibiotics 90 days prior to the participation on this study and not use fluoride mouthwashes.

Exclusion Criteria:

  • Exclusion criteria were: signs of uncontrolled systemic diseases (diabetes, high blood pressure and heart conditions), breast feeding or pregnant women, patients with oral tumors and patients with history of allergy to any of the materials used, such as Curcumin and Chlorhexidine.

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): NCT02337192


Locations
Brazil
Vitor Hugo Panhóca
São Carlos, SP, Brazil, 13560-970
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Vitor H Panhóca, Ms University of São Paulo.

Publications of Results:
1. Iliadi A, Baumgartner S, Athanasiou A, Eliades T, Eliades G. Effect of intraoral aging on the setting status of resin composite and glass ionomer orthodontic adhesives. American Journal of Orthodontics and Dentofacial Orthopedics 2014;145:425-433. 2. Corbett J, Brown L, Keene H, Horton I. Comparison of Streptococcus mutans concentrations in non-banded and banded orthodontic patients. Journal of Dental Research 1981;60:1936-1942. 3. Panhóca VH, Geralde MC, Corrêa TQ, Carvalho MT, Souza CWO, Bagnato VS. Enhancement of the Photodynamic Therapy Effect on Streptococcus Mutans Biofilm. Journal of Physical Science and Application 2014;4:107-114.

Responsible Party: Fernanda Rossi Paolillo, Vitor Hugo Panhóca, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02337192     History of Changes
Other Study ID Numbers: orto14
First Posted: January 13, 2015    Key Record Dates
Last Update Posted: January 13, 2015
Last Verified: January 2015

Keywords provided by Fernanda Rossi Paolillo, University of Sao Paulo:
Orthodontic, Photochemoterapy

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Bacterial Agents
Curcumin
Pulmonary Surfactants
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
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
Respiratory System Agents