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Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT02337192
Collaborator
(none)
24
Enrollment
1
Location
7
Arms
11
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
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 :
Jan 1, 2014
Actual Primary Completion Date :
Jun 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • Curcumin salt

    		•
    Experimental: Group 3

    Moutwash with Swish with Curcumin + SDS

    Drug: Curcumin
    Other Names:
  • 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 Names:
  • Curcumin salt

    • Device: LED
    Experimental: Group 6

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

    Drug: Curcumin
    Other Names:
  • Curcumin salt

    • Device: LED

    Drug: Surfactant
    Experimental: Group 7

    Positive control - Use of mouthwash with Chlorhexidine only

    Drug: Chlorhexidine gluconate

    Outcome Measures

    Primary Outcome Measures

    1. Microbiological analysis by the total number of colony-forming units (CFU) [one section ( one hour)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fernanda Rossi Paolillo, Vitor Hugo Panhóca, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT02337192
    Other Study ID Numbers:
    • orto14
    First Posted:
    Jan 13, 2015
    Last Update Posted:
    Jan 13, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Fernanda Rossi Paolillo, Vitor Hugo Panhóca, University of Sao Paulo
    Orthodontic, Photochemoterapy
    Additional relevant MeSH terms:
    Chlorhexidine
    Chlorhexidine gluconate
    Curcumin
    Pulmonary Surfactants

    Study Results

    No Results Posted as of Jan 13, 2015