Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment

NCT06764758 | Completed

• 1 other identifier: D-KA23/28
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Dental Anxiety

Keywords

dental anxiety; salivary cortisol; dental anxiety scale

Outcome Measures

Primary Outcomes (1)

• Corah's Dental Anxiety Scale

  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 Outcomes (1)

• Salivary Cortisol Levels

  Day 1 and day 7

Study Arms (2)

Endodontic treatment

ACTIVE COMPARATOR

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

Procedure: Endodontic treatment

Restorative treatment

ACTIVE COMPARATOR

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

Procedure: Restorative treatment

Interventions

Endodontic treatment PROCEDURE

Root-canal therapy applied in asymptomatic teeth with deep carious lesion required endodontic treatment.

Endodontic treatment

Restorative treatment PROCEDURE

Composite resin restoration applied in teeth previously applied endodontic treatment.

Restorative treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Dentistry, Ankara, Turkey

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Endodontics; Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• Kamran Gulsahi, DDS., PhD

  Baskent University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 8, 2025
• Study Start: February 27, 2024
• Primary Completion: September 24, 2024
• Study Completion: October 4, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after 6 months after article publication
• Access Criteria: for research purposes by contacting the first author via e-mail

Locations

TU (1)