Dental Anxiety in During Different Dental Treatments (DENANX) (DENANX)

Evaluation of Dental Anxiety in Patients Undergoing Different Dental Treatments - A Prospective Study

The aim of this observational cross-sectional study is to evaluate the dental anxiety levels of participants aged 18-70 years who will scheduled for different dental treatmentsThe main question it aims to answer is:

Does the type of dental treatment make a difference in the level of dental anxiety in participants? Within the scope of their dental treatment, participants who have already been planned to assign any of the filling, root canal treatments, scaling, tooth extraction and implant placement will have their anxiety levels recorded through a questionnaire just before starting treatment.

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Other: Modified Dental Anxiety Scale (MDAS)

• Study Type: Observational
• Enrollment (Actual): 322

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Aydın University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The cross-sectional survey-based research will be conducted on 322 volunteers aged 18 to 70 at Istanbul Aydin University Faculty of Dentistry between March 1, 2021, and April 30, 2021. Participants will be included in the study if they met the following criteria: voluntary participation, sufficient Turkish literacy, no recent psychiatric diagnoses within the previous year, no psychotherapy in the past six months, and no use of psychotropic drugs or illicit substances that could affect mental health in the previous year.

After a comprehensive oral and dental examination, an individualized treatment plan will be developed for each participants. These plans includes necessary dental procedures, such as fillings, root canals, scaling, tooth extractions, and implant procedures. The participants will be scheduled to receive their treatments on the seventh day, according to their individual needs. On that day, they will complete a survey while waiting in the waiting room.

Description

Inclusion Criteria:

• voluntary participation
• sufficient Turkish literacy
• no recent psychiatric diagnoses within the previous year
• no psychotherapy in the past six months,
• and no use of psychotropic drugs or illicit substances that could affect mental health in the previous year.

Exclusion Criteria:

-To stop volunteering until the study is completed.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Participants; Participants who are involved in the treatment planning of any of the following treatments: filling, root canal treatment, scaling, implant treatment and tooth extraction.	Other: Modified Dental Anxiety Scale (MDAS); The MDAS is described as a scale to provide a more comprehensive assessment of dental anxiety. The MDAS has shown favorable psychometric properties with acceptable reliability and validity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Dental Anxiety Scale	The data collection tool is an 8-question, 4-point Likert-type scale based on the MDAS, which has been validated for reliability and accuracy. The questions is designed to assess the anxiety levels of participants prior to scheduled dental procedures. The participants' responses are scored on a scale of 0-3 to indicate their level of anxiety and stress. A score of 0 indicated no anxiety, 1 indicated mild anxiety, 2 moderate indicated anxiety, and 3 indicated severe anxiety and stress. The dental anxiety level is determined based on the sum of scores given to the eight relevant questions, which ranged from 0 to 24 and is used to calculate the MDAS score. The MDAS score is then compared to the following cut-off values to determine the level of dental anxiety: a score of 0 indicated no anxiety, 1-8 indicated mild anxiety, 9-16 indicated moderate anxiety, and 17-24 indicated severe anxiety.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographical Outcomes	Demographic outcomes are as follows; age, sex, marital status, number of children, education level, and occupation.	1 hour
Oral and Dental Health Experiences and Attitudes	To assess participants' experiences and attitudes toward oral and dental health, including frequency of toothbrushing and dental treatment, previous dental experiences, and pre-treatment anxiety levels. In the questionnaire, which is a data collection tool, the frequency of tooth brushing is asked with the options of 1/day / 2 times a day / 1/week / 2-3 times a week, and the dental treatments in the past are asked to mark. They were also asked to tick how they found their experience (good/medium/bad) following these treatments. There are multiple choice questions to understand the presence of dental anxiety before treatment and what triggers it.	1 hour
Dental Anxiety Assessment	To assess participants' experience of dental anxiety, including its level, cause, onset, physical symptoms, and coping mechanisms. Additionally, it will be examined environmental triggers that contribute to dental anxiety, such as noise from equipment and the sight of sharp instruments, and the length of time it took for anxiety to peak. The objective of this section is to provide a comprehensive understanding of the participants' dental anxiety, its causes, and their self-coping strategies, as well as the impact of environmental factors on their anxiety levels.	1hour

Collaborators and Investigators

• Sponsor: Asst. Prof. Dr. Suleyman Emre Meseli

Publications and helpful links

General Publications

• Appukuttan DP. Strategies to manage patients with dental anxiety and dental phobia: literature review. Clin Cosmet Investig Dent. 2016 Mar 10;8:35-50. doi: 10.2147/CCIDE.S63626. eCollection 2016.
• Humphris G, Crawford JR, Hill K, Gilbert A, Freeman R. UK population norms for the modified dental anxiety scale with percentile calculator: adult dental health survey 2009 results. BMC Oral Health. 2013 Jun 24;13:29. doi: 10.1186/1472-6831-13-29.
• Kassem El Hajj H, Fares Y, Abou-Abbas L. Assessment of dental anxiety and dental phobia among adults in Lebanon. BMC Oral Health. 2021 Feb 4;21(1):48. doi: 10.1186/s12903-021-01409-2.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IAUDENT-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No