跳至主要内容
临床试验/NCT03462368
NCT03462368已完成不适用

Effects of Photobiomodulation and Antimicrobial Photodynamic Therapy Associated With Subepithelial Connective Tissue Graft on the Root Coverage of Multiple Gingival Recessions: A Randomized Controlled Clinical Trial.

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Total root coverage

研究概览

简要总结

The aim of this study was to evaluate the effect of two different treatment agents used in conjunction with subepithelial connective graft technique on root coverage outcomes in multiple recession defects. Half of patients will receive root treatment with antimicrobial photodynamic therapy and the other half will receive photobiomodulation therapy by laser on surgery site.

详细描述

Antimicrobial photodynamic therapy has been widely used in Periodontics to obtain reduction of periodontopathogenic bacteria with absence of systemic side effects and minimal bacterial resistance. Also, it has properties of root demineralization and exposure of collagen fibers. These properties may enhance root coverage in procedures of subepithelial connective graft. Laser photobiomodulation has the potential to increase healing and repair, this can generate gains in the root coverage and dental hypersensitivity.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Multiple Gingival recession - two or more Miller's class I or II (2 to 5 mm of height)
  • Indication of root coverage by dentin hypersensitivity or esthetic.
  • Minimum palate thickness (1,5mm)
  • Visible Enamel cement junction (JCE) on the teeth to be treated and pulp vitality
  • Patients without signs of periodontal disease activity and with plaque index and bleeding on probing throughout ≤20%;

排除标准

  • Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based contraceptives, steroids)
  • Pregnancy
  • Diabetics
  • History of head and neck radiotherapy
  • Teeth with mobility
  • Malpositioned teeth
  • History of periodontal surgery at the area on the last 12 months
  • Patients with orthodontic therapy in progression

结局指标

主要结局

Total root coverage

时间窗: One year

Total root coverage measured with a periodontal probe in millimeters. Ideal if the distance from cemento-enamel junction to gingival margin = 0 mm

次要结局

  • Probing depth(One year)
  • Clinical attachment level(One year)
  • Dentin hypersensitivity(One year)
  • Keratinized mucosa width(One year)

研究者

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

Carla Andreotti Damante

Associate professor

University of Sao Paulo

研究点 (2)

Loading locations...

相似试验