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临床试验/NCT06177158
NCT06177158尚未招募不适用

Efficacy of Oral Hygiene Instructions on Proinflammatory Cytokines Among Cigarette Smokers and Individuals Vaping Electronic Cigarettes During Plaque Induced Gingivitis (Clinical Trial)

University of Baghdad0 个研究点目标入组 39 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
39
主要终点
the reduction in periodontal parameters

研究概览

简要总结

To evaluate the level of proinflammatory cytokines in individual vaping electronic cigarette in gingivitis patients.

Can vaping affects the proinflammatory cytokines level in diseased individuals?

Group I: cigarette smoker with gingivitis. Group II: electronic cigarette smoker with gingivitis. Group III: non-smoker with gingivitis.

participants will be asked to perform oral hygiene instructions.

measurement of inflammatory biomarkers MMP8 and MMP9 base line and after intervention will be done.

详细描述

Periodontal diseases are defined as an inflammatory process associated with bacterial activity and mediated by the host's immunologic response (Armitage, 1999; Tonetti et al., 2018). Gingivitis, a reversible form of periodontal disease, is initially characterized by gingival inflammation cause by bacterial colonization forming the biofilm (Armitage, 1999; Tonetti et al., 2018). Cigarette smoking is a classical risk factor for both periodontal and peri-implant tissue damage (Sgolastra et al., 2013). It has been shown that patients who smoke suffer from more severe forms of periodontitis (Javed et al., 2013).

Disease progression is directly related to the frequency of smoking, where heavy smokers show more severe forms of the disease compared to light smokers (Tonetti et al., 2018). Different studies categorize the frequency of smoking differently but according to one review, smoking less than 9 cigarettes per day is considered light, and more than 31 is considered heavy smoking (Johnson & Guthmiller, 2000). Smoking also impacts the response to periodontal treatment; smokers show only 50%-75% improvement in their clinical parameters after scaling and root planing compared to non-smokers (Tonetti et al., 2018).

Another study analyzed the effects of cigarette smoking on periodontal parameters and found significant increases in plaque index, pocket depth, and clinical attachment loss levels in cigarette smokers compared to non-smokers (Javed et al., 2017). It has been evidenced that tobacco smoking results in a proinflammatory effect by stimulating the secretion of specific cytokines and radical oxygen species (ROS) that play a role in the destruction of periodontal tissues (Katz et al., 2005) Electronic cigarettes (e-cigs) are battery-operated handheld devices, in which an e-liquid (contain ning nicotine and sometimes artificial flavors such as menthol, coffee, candy, butter and fruits) is heated by a heating element releasing a chemical-filled aerosol for inhalation (Sundar et al., 2016).

In the United States (U.S.), the use e-cigs is escalating predominantly in younger adults (Delnevo et al., 2015). Vaping without nicotine still proposes risks of exposure to the chemicals that are released in the heating process of the device, such as aluminum, copper, and lead (Gaur & Agnihotri, 2019). E-cigarettes also pose a hazard for traumatic injuries. Blast injuries caused by battery explosion are also an associated risk, mainly in countries where there is no regulation on the manufacture and safety of e-cigarettes (Kite et al., 2016).

Focusing on a correlation between oral health and vaping, a recent study showed that e-cigarette exposure-mediated carbonyl stress leads to increased levels of prostaglandin-E2 and cyclooxygenase-2 in human gingival epithelium compared to control (Lerner et al., 2015) Several studies analyzed the impact of vaping on periodontal parameters and found increased levels of plaque index, pocket depth, clinical attachment loss, and marginal bone loss in vaping groups compared to non-smokers (Al-Aali et al., 2018) Despite all the evidence that smoking can negatively affect the periodontal tissues, there is still little evidence about the impact of vaping(Figueredo et al., 2020).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

lab technician and statistician will be masked

入排标准

性别
Male
接受健康志愿者

入选标准

  • the included participant will be patients smoking cigarette at least 12 months no more than 8 cigarettes per day, patients use electronic vape in categories of low to medium dependance according to the Penn state electronic cigarette dependence index (one time consist of around 15 puffs or last around ten minutes). participants who never consumed tobacco in any form during their lifetime, having minimum of 20 teeth, additionally, all of involved patients having generalized gingivitis with intact periodontium in which they have more than 10% bleeding sites with no PPD >3 mm with no clinical attachment loss according to criteria proposed by (Chapple in,2018).

排除标准

  • dual smokers, smokeless tobacco, heavy smokers, patient using high nicotine formula (more than 25 mg/ml), periodontitis patient, patient with systemic diseases, females, participants who had used antibiotics, steroidal or non-steroid anti-inflammatory drugs within the past 6 months, patients who had undergone periodontal therapy within the last 6 months and patients unwilling to participate in study.

结局指标

主要结局

the reduction in periodontal parameters

时间窗: 3 weeks

(PI,BOP and GI) between the baseline and the endpoints of the study.

次要结局

  • the changes between the baseline and 3 weeks for salivary matrix metalloproteinase 8 and 9 concentration.(three weeks)

研究者

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

Abdulrahman alauldin khazaal

B.D.S

University of Baghdad

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