Antimicrobial Photodynamic Therapy Applied in Orthodontic. Orthodontic Patients.

NCT ID: NCT02337192

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-12-31

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.

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.

Conditions

Dentist-Patient Relations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

DMSO + water

Intervention Type: DRUG

Group 2

Mouthwash with Swish with Curcumin

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Group 3

Moutwash with Swish with Curcumin + SDS

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Surfactant

Intervention Type: DRUG

Group 4

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

Group Type: EXPERIMENTAL

LED

Intervention Type: DEVICE

Group 5

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

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

LED

Intervention Type: DEVICE

Group 6

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

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

LED

Intervention Type: DEVICE

Surfactant

Intervention Type: DRUG

Group 7

Positive control - Use of mouthwash with Chlorhexidine only

Group Type: EXPERIMENTAL

Chlorhexidine gluconate

Intervention Type: DRUG

Interventions

Curcumin

Intervention Type: DRUG

LED

Intervention Type: DEVICE

Surfactant

Intervention Type: DRUG

DMSO + water

Intervention Type: DRUG

Chlorhexidine gluconate

Intervention Type: DRUG

Other Intervention Names

Curcumin salt

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Rossi Paolillo

Vitor Hugo Panhóca

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vitor H Panhóca, Ms

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Vitor Hugo Panhóca

São Carlos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

PMID: 24703280 (View on PubMed)

Other Identifiers

orto14

Identifier Type: -

Identifier Source: org_study_id