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临床试验/NCT06764758
NCT06764758已完成不适用

Short-Term Clinical Comparison of Anxiety Levels With Salivary Cortisol Levels in Patients Undergoing Endodontic and Restorative Treatment

Baskent University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年2月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Corah's Dental Anxiety Scale

研究概览

简要总结

This study aimed to compare the stress levels induced in patients at the beginning and at the end of endodontic and restorative treatments and access relationship between dental anxiety levels and cortisol levels.

For this study, 44 patients requiring endodontic and restorative treatment on a maxillary premolar tooth were selected. Patients were requested to fill out the Corah Dental Anxiety Scale (CDAS) questionnaire prior to and following each treatment procedure. Saliva samples were then collected using the roll cotton method. The saliva was analysed by using the Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) method. Intragroup comparisons of CDAS and cortisol levels were conducted using the Wilcoxon Signed Rank Test. Intergroup comparisons were performed employing the Mann-Whitney U Test. The magnitude of the association between continuous variables was investigated by calculating Spearman's rank-order correlation coefficients along with corresponding significance levels (p< 0.05).

详细描述

Anxiety is a psychological state defined as significant worry, fear, and tension in response to perceived threats, dangers, or uncertainties. A key long-term consequence of stress exposure is an increased release of cortisol, a hormone regulated by the activation of the hypothalamic-pituitary-adrenal (HPA) axis and the adrenal glands. Cortisol is integral to the body's stress response, with its levels increasing notably during episodes of anxiety, thereby triggering physiological changes.

Dental anxiety, specifically, refers to an intense fear and apprehension associated with dental treatments. This type of anxiety may be associated with several factors, such as negative dental experience, the nature of dental procedures, or individual perception of treatment. Moreover, demographic factors like socioeconomic status, sex, education, and age can impact the development of dental anxiety. Also, childhood experiences of traumatic dental treatments are another critical factor, often resulting in negative attitudes toward dental care.

Research shows that dental anxiety tends to peak during procedures involving injections, though other treatments like dental restorations, endodontic treatment, and tooth extractions are also major sources of distress. Various approaches are utilized to assess dental anxiety, including measuring cortisol levels, administering self-report questionnaires, and using pain rating scales. Commonly applied tools include the Spielberger State-Trait Anxiety Inventory (STAI), Corah's Dental Anxiety Scale (CDAS), Dental Fear Survey (DFS), and the Modified Dental Anxiety Scale (MDAS).

The null hypothesis proposes that endodontic and restorative procedures evoke similar anxiety levels in patients, with no significant association detected between salivary cortisol levels and CDAS measurements.

研究设计

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

入排标准

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

入选标准

  • •Participants over 18 years old
  • •Participants who are classified as ASA I according to the American Society of Anaesthesiologists (ASA) physical status classification system.
  • •Patients who require root canal treatment and will have composite restoration afterwards.

排除标准

  • •Patients with communication and cooperation problems.
  • •Patients who take medication regularly.
  • •Conditions such as Sjögren's syndrome or xerostomia, which affect salivary flow.
  • •Pregnancy.
  • •Patients with systemic diseases.

研究组 & 干预措施

Endodontic treatment

Active Comparator

gutta-percha (Sure Dent Corporation; Gyeonggi-do, Korea)

干预措施: Endodontic treatment (Procedure)

Restorative treatment

Active Comparator

Composite resin restorative material (3M Espe Filtek; Lake County, Minnesota, USA)

干预措施: Restorative treatment (Procedure)

结局指标

主要结局

Corah's Dental Anxiety Scale

时间窗: Day 1 and day 7

The general anxiety level associated with dental procedures was assessed through the Corah Dental Anxiety Scale (CDAS), which includes of four questions designed to evaluate the patient's dental anxiety level. The results were evaluated using a scoring system ranging from 4 (no anxiety) to 20 (high anxiety).

次要结局

  • Salivary Cortisol Levels(Day 1 and day 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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