NCT06485973

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 21, 2024

Last Update Submit

June 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Demographical Outcomes

    1 hour

  • Oral and Dental Health Experiences and Attitudes

    1 hour

  • Dental Anxiety Assessment

    1hour

Study Arms (1)

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)

Interventions

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.

All Participants

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • To stop volunteering until the study is completed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydın University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27022303BACKGROUND
  • 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.

    PMID: 23799962BACKGROUND
  • 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 Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof. Suleyman Emre MESELI, PhD, DDS

Study Record Dates

First Submitted

June 21, 2024

First Posted

July 3, 2024

Study Start

March 1, 2021

Primary Completion

April 30, 2021

Study Completion

September 30, 2022

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations