Dental AnxietyNCT06385314
A Cross Sectional Study on Dental Anxiety and State Anxiety Related to Removal of Fixed Partial Dentures
An observational study of Dental Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Collecting data with oral health related quality of life, dental anxiety and state anxiety
- Type of treatment
- Pill or oral medicine
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 29 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Anxiety
- Being tested
- Collecting data with oral health related quality of life, dental anxiety and state anxiety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting data with oral health related quality of life, dental anxiety and state anxietyOther
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 group | Role | What they receive |
|---|---|---|
| Oral examination | remove of fixed partial denture for oral examination Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Collecting data with oral health related quality of life, dental anxiety and state anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
United Kingdom Oral Health-Related Quality-of-Life Measure
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.
Measured: baseline
Modified Dental Anxiety Scale
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.
Measured: baseline
Spielberger State Anxiety Inventory
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.
Measured: baseline
Spielberger Trait Anxiety Inventory
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start5 Sep 2022
- Primary completion25 Nov 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kubra Degirmenci, Dr, Principal investigator, Kubra Degirmenci Faculty of Dentistry Department of Prosthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06385314
- Sponsor's protocol ID
- Degirmenci1499
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Removal of Fixed Partial Dentures on the Grade of Dental Anxiety and State Anxiety a Cross Sectional Study
- ClinicalTrials.gov ID
- NCT06385314
- Acronym / sponsor ID
- Degirmenci1499
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Oral examination | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for oral examination |
| Denture renewal | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for denture renewal |
| Root canal treatment | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for root canal treatment |
| Tooth extraction | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for tooth extraction |
| Periodontal treatment | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for periodontal treatment |
| Composite filling restoration | – | Other: Collecting data with oral health related quality of life, dental anxiety and state anxietyremove of fixed partial denture for composite filling restoration |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting data with oral health related quality of life, dental anxiety and state anxietyCollecting 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. | Other | Composite filling restoration, Denture renewal, Oral examination, Periodontal treatment, Root canal treatment, Tooth extraction |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kubra Degirmenci, Dr principal investigator
Kubra Degirmenci Faculty of Dentistry Department of Prosthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Anxiety, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
United Kingdom Oral Health-Related Quality-of-Life Measure (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.