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临床试验/NCT04833569
NCT04833569已完成1 期

Clinical, Bacterial, and Inflammatory Outcomes of Indocyanine Green-mediated Photodynamic Therapy for Treating Periimplantitis Among Diabetic Patients: a Randomized Controlled Clinical Trial

King Saud University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年9月20日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
2
主要终点
Probing depth

研究概览

简要总结

In this study, the effect of photodynamic therapy (indocyanine green mediated) on the clinical, biological and inflammatory aspects was assessed in diabetic patients having peri-implantitis

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 (Outcomes Assessor)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients above 45 years of age having type 2 DM
  • HbA1c (≥6.5%) and fasting glucose test
  • probing depth ≥6 mm with bleeding and/or suppuration on at least one site around dental implants that remained in situ
  • On radiographic assessment, the implants exhibited ≥ 3 mm alveolar bone loss apical to the coronal region of the intraosteal portion of the dental implant.
  • Exclusion Criteria Patients were excluded if they indicated current or former history of tobacco smoking, any systemic disease other than DM, enrolled in a non-surgical periodontal maintenance program, history of implant repair, pregnancy, and part six months use of antimicrobials, non-steroidal anti-inflammatory drugs, bisphosphonates, or corticosteroids.

排除标准

  • 未提供

结局指标

主要结局

Probing depth

时间窗: 6 months

Measurement of consecutive millimeter markings of the periodontal pocket depth

Suppuration

时间窗: 6 months

Presence or absence of pus

Bleeding on probing

时间窗: 6 months

Presence or absence of bleeding indicated as '1' or '0', respectively

Plaque index

时间窗: 6 months

Presence or absence of plaque indicated as '1' or '0', respectively.

Crestal bone loss

时间窗: 6 months

Measurement of consecutive millimeter markings of the alveolar bone levels

次要结局

  • Interleukin-6(6 months)
  • Microbiological analysis (Treponema denticola)(6 months)
  • HbA1c(6 months)
  • Interleukin-1 beta(6 months)
  • Microbiological analysis (Porphyromonas gingivalis)(6 months)

研究者

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

Labban Nawwaf

Department of Prosthetic Dental Sciences, College of Dentistry, King Saud University

King Saud University

研究点 (2)

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