The Role of Smoking and Gingival Crevicular Fluid Markers on Coronally Advanced Flap Outcomes
2018年5月25日 更新者：Nurcan Buduneli、Ege University
Cigarette smoking is a patient-related factor that can affect healing of periodontal tissues and the success rate of root-coverage procedures.
Neither the nature nor the mechanisms of action of cigarette smoking on root coverage are fully understood.
Therefore, the hypothesis that cigarette smoking has negative impacts on the outcomes of root coverage after CAF surgery in systemically healthy individuals with an initial gingival thickness of at least 0.8 mm and who practice optimal oral hygiene was tested.
It was also hypothesized that baseline analysis of disease-related biomarkers would shed light on the underlying mechanisms of a possible effect.
研究概览
研究类型
介入性
注册 (实际的)
15
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Maxillary central and lateral incisors, canines, and premolars and mandibular premolars with isolated buccal recessions classified as Miller Class I or II
- Study tooth should present tooth vitality, identifiable cemento-enamel junction (CEJ) and absence of caries, restorations or extensive non-carious cervical lesion.
Exclusion Criteria:
- Medical disorders such as diabetes mellitus, immunologic disorders, hepatitis
- History of previous mucogingival surgery at the gingival recession site
- Medications known to affect gingival tissues
- Antibiotic treatment in the past 6 months
- Pregnancy or lactation
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Smoker Group
This group included smoker gingival recession patients.
|
The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery.
The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location.
CAF is mainly used for the treatment of gingival recessions.
|
|
有源比较器：Non-smoker Group
This group included non-smoker gingival recession patients.
|
The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery.
The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location.
CAF is mainly used for the treatment of gingival recessions.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the percentage of root coverage
大体时间：1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
Root coverage were measured on digital photographs using specific software.
|
1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in the percentage of complete root coverage
大体时间：1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
|
|
Change in gingival thickness
大体时间：Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
Gingival thickness was measured with an ultrasonic device that uses the pulse echo principle.
Ultrasonic pulses are transmitted at intervals of 1 millisecond through the sound-permeable mucosa and reflected, in part, at the surface of the alveolar bone or tooth attributable to different acoustic impedance.
When an acoustic signal is transmitted within 2 to 3 seconds, gingival thickness is digitally displayed with a sensitivity of 0.01 mm.
|
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
|
Changing of the gingival crevicular fluid (GCF) biomarkers
大体时间：Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
|
|
Changing of the salivary biomarkers
大体时间：Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
Baseline,1-month, 3-month and 6-month after coronally advanced flap (CAF)
|
|
|
Change in the visual analog scale (VAS) values
大体时间：1 to 7 day after coronally advanced flap (CAF)
|
The visual analog scale (VAS) was used to evaluate pain during the postoperative follow-up period.
It consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'.
The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the no pain and 10 being the worst pain.
|
1 to 7 day after coronally advanced flap (CAF)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2010年5月3日
初级完成 (实际的)
2012年6月7日
研究完成 (实际的)
2013年1月7日
研究注册日期
首次提交
2018年5月15日
首先提交符合 QC 标准的
2018年5月25日
首次发布 (实际的)
2018年5月30日
研究记录更新
最后更新发布 (实际的)
2018年5月30日
上次提交的符合 QC 标准的更新
2018年5月25日
最后验证
2018年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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