- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06385314
A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
April 22, 2024 updated by: Abant Izzet Baysal University
The Effect of Removal of Fixed Partial Dentures on the Grade of Dental Anxiety and State Anxiety a Cross Sectional Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bolu, Turkey
- Kubra Degirmenci
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Oral examination
remove of fixed partial denture for oral examination
|
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.
|
|
Denture renewal
remove of fixed partial denture for denture renewal
|
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.
|
|
Root canal treatment
remove of fixed partial denture for root canal treatment
|
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.
|
|
Tooth extraction
remove of fixed partial denture for tooth extraction
|
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.
|
|
Periodontal treatment
remove of fixed partial denture for periodontal treatment
|
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.
|
|
Composite filling restoration
remove of fixed partial denture for composite filling restoration
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
|
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.
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kubra Degirmenci, Dr, Kubra Degirmenci Faculty of Dentistry Department of Prosthodontics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2022
Primary Completion (Actual)
November 25, 2023
Study Completion (Actual)
December 29, 2023
Study Registration Dates
First Submitted
April 4, 2024
First Submitted That Met QC Criteria
April 22, 2024
First Posted (Actual)
April 26, 2024
Study Record Updates
Last Update Posted (Actual)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 22, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Degirmenci1499
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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