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临床试验/NCT06525363
NCT06525363已完成1 期

Clinical Assessment of Chitosan Nano-particles on Periodontal Problems Post Steroidal Inhalation in Asthmatic Patients: Phase I Trial

Deraya University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年8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
入组人数
20
试验地点
1
主要终点
Levels of oral Streptococcus mutans

研究概览

简要总结

Periodontal problems management is the most important goals of chronic asthmatic patients that adapted to use steroid inhalation for long time. Gram negative anaerobic bacteria are generally suggested as the primary cause of Periodontal problems and mechanical procedure is the treatment approach, which is performed nonsurgical or surgically. The understanding of the role of bacteria in the initiation and progression of periodontal disease has led to great interest in the use of antibiotics to suppress or eradicate pathogenic macrobiotic. Systemic antibiotics have been used in different forms of periodontal disease treatment. Systemic antibiotics can penetrate soft tissues and may target invasive organisms, can be used to treat multiple sites simultaneously, and may also affect reservoirs of bacterial reinfection such as saliva, the tonsils, and the oral mucosa. However, there may be problems associated with the use of systemic antibiotics such as the development of resistant bacteria, and potential side effects (hypersensitivity reactions, gastrointestinal discomfort, etc.). so in this study we aimed at To evaluate the effect of chitosan nanoparticle spray in management of dental problems in asthmatic patients receiving corticosteroids inhaler that support the growth of bacteria in periodontal area.

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, Investigator)

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

  • Age from 18-50 years old
  • Both sex male and female
  • Patients diagnosed as Asthmatic
  • Patients treated with corticosteroids inhaler or ( beta2-adrenergic agonist inhaler or nebulizer for their symptoms)

排除标准

  • Patients treated with other medication
  • Patients not diagnosed as asthmatic
  • Comorbidity

研究组 & 干预措施

treatment group

Experimental

chitosan nanoparticles spray 1% w/w twice daily

干预措施: Chitosan (Drug)

结局指标

主要结局

Levels of oral Streptococcus mutans

时间窗: each 3 weeks for 12 weeks

counting number of of S. mutans will be obtained by culture and be expressed in colony forming units (CFUs)

Plaque Examination

时间窗: each 3 weeks for 12 weeks

Plaque is recorded using the plaque index (PI)

The inflammatory status of the gingiva

时间窗: each 3 weeks for 12 weeks

recorded using the gingival index (GI)

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

Soad Ali

associate professor of pharamcy practices, faculaty of pharmacy, Deraya University

Deraya University

研究点 (1)

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