Clinical trial NCT06764758: Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment
Official title: Short-Term Clinical Comparison of Anxiety Levels With Salivary Cortisol Levels in Patients Undergoing Endodontic and Restorative Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Keywords: dental anxiety
salivary cortisol
dental anxiety scale
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Corah's Dental Anxiety Scale
timeFrame: Day 1 and day 7
Secondary outcomes:
measure: Salivary Cortisol Levels
timeFrame: Day 1 and day 7
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University Faculty of Dentistry, Ankara, Turkey
Study officials:
affiliation: Baskent University Faculty of Dentistry
name: Kamran Gulsahi, DDS., PhD
role: STUDY_CHAIR
References: