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临床试验/NCT02337192
NCT02337192已完成1 期

Oral Decontamination Using Antimicrobial Photodynamic Therapy Applied in Orthodontic Patients.

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Microbiological analysis by the total number of colony-forming units (CFU)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Group 3

Experimental

Moutwash with Swish with Curcumin + SDS

干预措施: Surfactant (Drug)

Group 4

Experimental

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

干预措施: LED (Device)

Group 5

Experimental

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

干预措施: Curcumin (Drug)

Group 1

Experimental

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

干预措施: DMSO + water (Drug)

Group 2

Experimental

Mouthwash with Swish with Curcumin

干预措施: Curcumin (Drug)

Group 3

Experimental

Moutwash with Swish with Curcumin + SDS

干预措施: Curcumin (Drug)

Group 5

Experimental

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

干预措施: LED (Device)

Group 6

Experimental

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

干预措施: Curcumin (Drug)

Group 6

Experimental

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

干预措施: LED (Device)

Group 6

Experimental

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

干预措施: Surfactant (Drug)

Group 7

Experimental

Positive control - Use of mouthwash with Chlorhexidine only

干预措施: Chlorhexidine gluconate (Drug)

结局指标

主要结局

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

时间窗: one section ( one hour)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernanda Rossi Paolillo

Vitor Hugo Panhóca

University of Sao Paulo

研究点 (1)

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