Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment

January 3, 2025 updated by: Baskent University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06490
        • Baskent University Faculty of Dentistry, Ankara, Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Endodontic treatment
gutta-percha (Sure Dent Corporation; Gyeonggi-do, Korea)
Procedure: Endodontic treatment
Root-canal therapy applied in asymptomatic teeth with deep carious lesion required endodontic treatment.
Active Comparator: Restorative treatment
Composite resin restorative material (3M Espe Filtek; Lake County, Minnesota, USA)
Procedure: Restorative treatment
Composite resin restoration applied in teeth previously applied endodontic treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corah's Dental Anxiety Scale
Time Frame: 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).
Day 1 and day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary Cortisol Levels
Time Frame: Day 1 and day 7
In evaluating the patients' stress levels through experimental and chemical tests, the method of measuring cortisol levels from salivary samples was preferred. The results were evaluated using a scoring system ranging from 1.4 (low salivary cortisol level) -10.1(high salivary cortisol level) ng/ml.
Day 1 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Study Chair: Kamran Gulsahi, DDS., PhD, Baskent University Faculty of Dentistry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2024

Primary Completion (Actual)

September 24, 2024

Study Completion (Actual)

October 4, 2024

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-KA23/28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified data will be made available by contacting the first author

IPD Sharing Time Frame

Data will be available after 6 months after article publication

IPD Sharing Access Criteria

for research purposes by contacting the first author via e-mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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