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临床试验/NCT05276817
NCT05276817已完成1 期

Microbiological Evaluation of Diode Laser Bacterial Reduction as Adjunct to Periodontal Maintenance Treatment: A Pilot Clinical Study

Biolase Inc1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
Biolase Inc
入组人数
14
试验地点
1
主要终点
Bacteria concentration measured by qPCR

研究概览

简要总结

The primary aim of this pilot study is to determine whether the test methods described feasibly achieve the goal defined for a future clinical study. The purpose is a quantitative assessment of the bactericidal effect of two adjunctive treatments compared to that of conventional periodontal maintenance debridement. Patients who meet eligibility criteria and are enrolled in the study will receive the standard of care, whole mouth periodontal maintenance treatment using ultrasonic scalers to debride deposits within the gingival sulcus. Subsequently, each of three of the quadrants will be randomly assigned to a test group (keeping the fourth quadrant as the control), thus, a "split-mouth" study design. Microbial samples will be collected using sterile paper points inserted into each tooth site involved in the study at baseline (S1) before test treatment and one week after test treatment (S2). Samples will be analyzed with real time qPCR to identify and quantify specific periodontal pathogens. Data analysis will compare the post-treatment results to baseline, the control treatment arm to the test treatment arm, and the test treatments among each other.

研究设计

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

入排标准

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

入选标准

  • • Adults, over 30 years old
  • At least one site in each quadrant having CAL 4-6mm and/or PPD 5-7mm (at least 4 sites per patient) with all adjacent sites having PPD<5mm
  • Patients who received SRP treatment in the past 12 months, who are returning for routine periodontal maintenance debridement, whose pockets are stable at PPD 5-7mm (not showing improvement or decline)

排除标准

  • • Patients who have had periodontal surgery within 12 months
  • A site adjacent to the potential study site having either an implant placed or a PPD>7mm
  • Patients taking systemic antibiotics or immunosuppressants during or within 3 months of the study
  • Chronic smokers or smokeless tobacco users

研究组 & 干预措施

Perio maint. then sham laser

Sham Comparator

干预措施: Sham (Device)

Perio maint. then medicament

Experimental

干预措施: HP (Drug)

Perio maint. then diode laser 1

Experimental

干预措施: Epic Diode (Device)

Perio maint. then diode laser 2

Experimental

干预措施: Epic Diode (Device)

结局指标

主要结局

Bacteria concentration measured by qPCR

时间窗: 1 week

Change in levels of the total bacterial load and of individual bacteria from baseline and compared to control.

次要结局

  • Incidence of adverse events(3 months)

研究者

发起方
Biolase Inc
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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