Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.

Dentist-Patient Relations Clinical Trial

Official title:

Oral Decontamination Using Antimicrobial Photodynamic Therapy Applied in Orthodontic Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337192
• Other study ID #: orto14
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2014
• Last updated: January 8, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentist-Patient Relations

Intervention

Drug:
• Curcumin

Device:
• LED

Drug:
• Surfactant

• DMSO + water

• Chlorhexidine gluconate

Locations

Country	Name	City	State
Brazil	Vitor Hugo Panhóca	São Carlos	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. C

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological analysis by the total number of colony-forming units (CFU)		one section ( one hour)	Yes