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

• ClinicalTrials.gov Identifier: NCT06385314
• Recruitment Status: Completed
• First Posted: April 26, 2024
• Last Update Posted: April 26, 2024
• Sponsor: Abant Izzet Baysal University
• Information provided by (Responsible Party): Abant Izzet Baysal University

Tracking Information

• First Submitted Date: April 4, 2024
• First Posted Date: April 26, 2024
• Last Update Posted Date: April 26, 2024
• Actual Study Start Date: September 5, 2022
• Actual Primary Completion Date: November 25, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 22, 2024)

• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
• Official Title: The Effect of Removal of Fixed Partial Dentures on the Grade of Dental Anxiety and State Anxiety a Cross Sectional Study
• Brief Summary: 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.
• Detailed Description: 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.
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: The population of this cross-sectional study was formed from volunteer participants who presented to the clinic of the Faculty of Dentistry of University between September 2022 and December 2023 and had fixed partial dentures that needed to be removed.
• Condition: Dental Anxiety

Intervention

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

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.

Study Groups/Cohorts

• Oral examination
  remove of fixed partial denture for oral examination
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety
• Denture renewal
  remove of fixed partial denture for denture renewal
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety
• Root canal treatment
  remove of fixed partial denture for root canal treatment
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety
• Tooth extraction
  remove of fixed partial denture for tooth extraction
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety
• Periodontal treatment
  remove of fixed partial denture for periodontal treatment
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety
• Composite filling restoration
  remove of fixed partial denture for composite filling restoration
  Intervention: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 22, 2024): 300
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 29, 2023
• Actual Primary Completion Date: November 25, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Individuals between the ages of 30 and 65, individuals who are literate and have documented evaluations,
2. Individuals who do not have any physical and psychological health problems,
3. Individuals who do not receive any psychiatric treatment and do not use anxiolytic drugs
4. 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:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06385314
• Other Study ID Numbers: Degirmenci1499
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Abant Izzet Baysal University
• Original Responsible Party: Same as current
• Current Study Sponsor: Abant Izzet Baysal University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kubra Degirmenci, Dr; Kubra Degirmenci Faculty of Dentistry Department of Prosthodontics

• PRS Account: Abant Izzet Baysal University
• Verification Date: April 2024