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Completed

NCT Number: NCT06385314

A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures

This study aims to evaluate the effect of the clinical removal of fixed partial dentures (FPDs) on oral health-related quality of life (OHRQoL) and the anxiety values of individuals and to determine the risk factors of high anxiety levels. 300 participants were included in this study. Six different reasons for the clinical removal of FPDs (oral examination, denture renewal, root canal treatment, tooth extraction, periodontal treatment, and composite filling restoration) were defined. Questions pertaining to the United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK), the Modified Dental Anxiety Scale (MDAS), and the Spielberger State-Trait Anxiety Inventory - State (STAI-S) and Trait (STAI-T) were answered.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kubra Degirmenci

Bolu, Turkey (Türkiye)

About this study

Data were obtained by questionnaires (United Kingdom Oral Health-Related Quality-of-Life Measure, the Modified Dental Anxiety Scale, the Spielberger State-Trait Anxiety Inventory - State and Trait) after written consent was obtained from all participants. The United Kingdom Oral Health-Related Quality-of-Life Measure (OHQoL-UK) scale is a Likert-type scale, which evaluates the effects of individuals' OHRQoL on 16 main areas in four different categories (symptoms, physical condition, psychological status, and social status) in both positive areas and negative areas, where "1" indicates a very bad impact, "2" denotes a bad effect, "3" represents no effect, "4" indicates a good effect and "5" denotes a very good impact. The minimum and maximum scores can be recorded: 2-10 for the symptom category, 5-25 for the physical condition category, 5-25 for the psychological state category, and 4-20 for the social status category, while the total OHQoL-UK score can be recorded as 16-80. A high OHRQoL score indicates a high quality of life in the relevant category. The Modified Dental Anxiety Scale (MDAS) measures dental anxiety with five questions. The total score can be obtained by adding the scores obtained from five different answer options ranging from 1 (not anxious) to 5 (extremely anxious) in response to the answers given to the five questions about dental anxiety. The total scores of MDAS, which ranged from 5-25, can be divided into two categories "no dental anxiety to moderate dental anxiety" (5-18) and "high dental anxiety" (19-25) points. Spielberger State-Trait Anxiety Inventory has two subscales state anxiety- STAI-S and trait anxiety STAI-T. STAI- state anxiety, measures subjective feelings of apprehension, 'anxious' expectation. STAI- trait anxiety, measures individual differences in anxiety proneness. The STAI consists of 40 items, 20 for each subscale. Items are ordered on a Likert scale from 1 (not at all/almost never) to 4 (very much so/almost always), and some items are reverse-scored. Individuals are asked to indicate how they feel "right now, at this moment" for the STAI-state and how they "generally feel" for the STAI-trait. State (STAI-S) and Trait (STAI-T) scores are obtained by the reverse expressions subtracted from the score of the direct expressions and adding the constant 50 to the state score and the constant 35 to the trait score. A high STAI-S and STAI-T scores indicate a high level of anxiety. Individuals with scores ≥45 on the STAI-S and STAI-T scales can be classified as having high anxiety.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals between the ages of 30 and 65, individuals who are literate and have documented evaluations,
  • Individuals who do not have any physical and psychological health problems,
  • Individuals who do not receive any psychiatric treatment and do not use anxiolytic drugs
  • Individuals who have metal framework porcelain FPDs that need to be removed and are coming in for their removal appointments Individuals who do not have temporomandibular joint problems and neuromuscular disease

Exclusion criteria

  • Individuals who have a psychological or psychiatric disorder and use medication,
  • Individuals who have implant-supported FPDs,
  • Individuals who have all-ceramic FPDs or removable dentures,
  • Individuals who have pain that requires emergency intervention
  • Individuals who do not want to be a participant

Treatment and study plan

Collecting data with oral health related quality of life, dental anxiety and state anxiety

Other

Collecting data through surveys regarding the patient's oral health related quality of life, dental anxiety and state anxiety before the fixed partial dentures that need to be removed for various clinical reasons are removed.

Primary outcomes

  1. United Kingdom Oral Health-Related Quality-of-Life Measure

    Time frame: baseline

    United Kingdom Oral Health-Related Quality-of-Life scale evaluates the effects of individuals' oral health related quality of life.

    Minimum total United Kingdom Oral Health-Related Quality-of-Life scale can be 16. Maximum total United Kingdom Oral Health-Related Quality-of-Life scale score can be 80. Higher scores means a better outcome.

  2. Modified Dental Anxiety Scale

    Time frame: baseline

    Modified Dental Anxiety Scale evaluates dental anxiety of individuals. Minimum total Modified Dental Anxiety Scale score can be 5. Maximum total Modified Dental Anxiety Scale score can be 25. Higher scores means a worse outcome.

  3. Spielberger State Anxiety Inventory

    Time frame: baseline

    Spielberger State Anxiety Inventory evaluates state anxiety of individuals. Minimum total Spielberger State Anxiety Inventory score can be 20. Maximum total Spielberger State Anxiety Inventory score can be 80. Higher scores means a worse outcome. The scores ≥45 on the Spielberger State Anxiety Inventory is classified as having high state anxiety.

  4. Spielberger Trait Anxiety Inventory

    Time frame: baseline

    Spielberger Trait Anxiety Inventory evaluates trait anxiety of individuals. Minimum total Spielberger Trait Anxiety Inventory score can be 20. Maximum total Spielberger Trait Anxiety Inventory score can be 80. Higher scores means a worse outcome. The scores ≥45 on the Spielberger Trait Anxiety Inventory is classified as having high trait anxiety.

Sponsors and collaborators

Lead sponsor

Abant Izzet Baysal University

Other

Registry information

Official study title

The Effect of Removal of Fixed Partial Dentures on the Grade of Dental Anxiety and State Anxiety a Cross Sectional Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2024
Registry last updated
Apr 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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