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临床试验/NCT02479958
NCT02479958已完成1 期

A Randomized in Vitro Evaluation of Antimicrobial Photodynamic Therapy on Deciduous Carious Dentin

University of Sao Paulo0 个研究点目标入组 58 人开始时间: 2011年5月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
58
主要终点
Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)

研究概览

简要总结

Despite of the decline of dental caries, this disease is still common in polarized groups affecting children. Therefore, the aim of this randomized blind in vivo study was to compare the antimicrobial effect of two antimicrobial therapies in deciduous carious dentin. Thirty two patients aging from 5 to 7 years old had partial caries removal in deep carious dentin lesion in deciduous molar and were divided in three groups: 1. Control - chlorhexidine and resin modified glass ionomer cement (RMGIC); 2. LEDTB - antimicrobial photodynamic therapy (APDT) with LED (light emission diode) associated with toluidine blue orto dye solution and RMGIC; 3. LMB - APDT with laser associated with methylene blue dye solution and RMGIC. The patients were submitted to initial clinical and radiographic examination and demographic features were evaluated by biofilm, gingival, and dmft/dmfs indexes, besides clinical and radiographic follow up at 6 and 12 months after the treatments. The carious dentin was collected before and after each treatment and the number of Streptococcus mutans, Streptococcus sobrinus, Lactobacillus casei, Fusobacterium nucleatum, Atopobium rimae and total bacteria were established by quantitative PCR.

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
Single (Participant)

入排标准

年龄范围
5 Years 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria consisted of good general health, without syndromes or chronic systemic diseases. They should also have at least one primary molar with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits.

排除标准

  • Children whose parents refused to sign the informed consent document, who did not cooperate with the clinical exams, whose teeth had the treatment choice changed (pain or evolution to irreversible pulpits), who did not attend to the appointments for the scheduled treatments, or who needed antibiotics treatment for other medical reasons were excluded from the study without prejudice.

结局指标

主要结局

Quantification of Bacteria by quantitative Polymerase Chain Reaction (PCR)

时间窗: 15 days after dentin collection

Quantification of S. mutans, L. casei, F. nucleatum, A. rimae and total bacteria by PCR (Polymerase Chain Reaction)

次要结局

  • Restoration Quality(12 months)
  • Tooth Pain(12 months)

研究者

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

Carolina Steiner-Oliveira

PhD

University of Sao Paulo

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