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临床试验/NCT04172207
NCT04172207已完成不适用

Effects of Antibiotic Consumption Time on Gingival-biopsy and Oral-smear Samples.

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Effects of antibiotics on gingiva confirmed by histopathology.

研究概览

简要总结

Antimicrobial or antibiotic agents, which are essential to prevent and treat bacterial infectious diseases, have become one of the most widely used drugs in the world. In the European region, the highest rates of antibiotic consumption are reported in Turkey. There is a nearly fivefold difference between Turkey and the lowest consuming countries.

Studies in dentistry evaluate participants according to the basis of predefined criteria. History of antibiotic consumption is one of the most common exclusion criteria for periodontal trials. However, there is still disagreement on how long the effect of systemic antibiotic agents on the oral mucosa and periodontal tissue lasts. It is unclear whether the timing of antibiotic consumption should be an exclusion criterion for genetic damage and histological studies during the selection of healthy participants.

Periodontal status of participants in study groups is described as with or without periodontitis in many studies, because of the lack of clear definitions of periodontal health and gingivitis. It should be recognized that even the lack of visual signs of inflammation, some mild histopathological changes can be seen in the periodontium. Consequently, for the real diagnosis of the clinically healthy periodontium, clinical findings should be supported and confirmed with histological results.

Micronuclei (Mn) are observed as abnormal nuclear structures and indicators of chromosomal level DNA damage. The oral mucosa epithelium is an immunologic barrier and affected by chemical factors such as antibiotic consumption. The Mn test to exfoliated epithelial cells from the oral cavity is utilized as a non-invasive diagnostic technique for monitoring the status of oral health. To our knowledge, no studies have been conducted on the comparison of the impacts of the timing of antibiotic consumption on human periodontal tissues and oral smear samples. The present study is undertaken to determine whether the different timing of antibiotic (amoxicillin) therapy has effects on the histopathology of gingiva and genetic damage of exfoliated cells from oral mucosa in healthy participants.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Systemically and periodontally healthy participants
  • Presence of probing depth (PD) of ≤ 3 mm14 and bleeding on probing (BOP) ˂ 10%15
  • No clinical evidence of gingival recession (GR), clinic attachment loss or radiographic evidence of alveolar bone loss
  • No periodontal treatment within the last 12 months

排除标准

  • Smoking, alcohol or drug abuse
  • Any systemic condition would affect the periodontal health (i.e., pregnancy, lactation, ovulation, and diabetes mellitus)
  • A history of contagious disease
  • Periodontal treatment within the last 12 months

结局指标

主要结局

Effects of antibiotics on gingiva confirmed by histopathology.

时间窗: 1-week

Modified histological criteria was the measurement used for the semi-quantitative histological assessment of gingival damage. Cellular components, vascularization, cell infiltration, necrosis, pyknotic nucleus, hyperemia, fibrosis, ulceration, atrophy, apoptosis, and rete peg configuration were scored by using a scale ranging from 0 to 3 (none : 0, mild: 1, moderate: 2, and severe : 3) for each criterion.

Effects of antibiotics on buccal and oral smear confirmed by quantitative determination of the micronuclei.

时间窗: 1-week

The method has been applied both for monitoring chromosome damage and/or proteins may also result in unsuccessful attachment of a whole chromosome at anaphase stage which subsequently also gives rise to a micronucleus. Thus, quantitative determination of the micronuclei are unique amongst cytogenetic tests in that it provides a reliable measure of both chromosome loss and breakage.

次要结局

未报告次要终点

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Begum Alkan

Principal Investigator

Istanbul Medipol University Hospital

研究点 (1)

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