Dental AnxietyDENANXNCT06485973
Dental Anxiety in During Different Dental Treatments (DENANX)
An observational study of Dental Anxiety, run by Asst. Prof. Dr. Suleyman Emre Meseli at 1 site in Turkey (Türkiye).
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Modified Dental Anxiety Scale (MDAS)
- How many people
- 322 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Sep 2022
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -To stop volunteering until the study is completed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Dental Anxiety in Patients Undergoing Different Dental Treatments - A Prospective Study
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.
- Conditions
- Dental Anxiety
- Being tested
- Modified Dental Anxiety Scale (MDAS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Dental Anxiety Scale (MDAS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Modified Dental Anxiety Scale (MDAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (3)
Demographical Outcomes
Demographic outcomes are as follows; age, sex, marital status, number of children, education level, and occupation.
Measured: 1 hour
Oral and Dental Health Experiences and Attitudes
To assess participants' experiences and attitudes toward oral and dental health, including frequency of toothbrushing and dental treatment, previous dental experiences, and pre-treatment anxiety levels. In the questionnaire, which is a data collection tool, the frequency of tooth brushing is asked with the options of 1/day / 2 times a day / 1/week / 2-3 times a week, and the dental treatments in the past are asked to mark. They were also asked to tick how they found their experience (good/medium/bad) following these treatments. There are multiple choice questions to understand the presence of dental anxiety before treatment and what triggers it.
Measured: 1 hour
Dental Anxiety Assessment
To assess participants' experience of dental anxiety, including its level, cause, onset, physical symptoms, and coping mechanisms. Additionally, it will be examined environmental triggers that contribute to dental anxiety, such as noise from equipment and the sight of sharp instruments, and the length of time it took for anxiety to peak. The objective of this section is to provide a comprehensive understanding of the participants' dental anxiety, its causes, and their self-coping strategies, as well as the impact of environmental factors on their anxiety levels.
Measured: 1hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Mar 2021
- Primary completion30 Apr 2021
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- 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
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asst. Prof. Dr. Suleyman Emre Meseli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asst. Prof. Dr. Suleyman Emre Meseli, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06485973
- Sponsor's protocol ID
- IAUDENT-01
- Acronym
- DENANX
- Status last verified
- Jun 2024
- First submitted
- 21 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27022303Humphris 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.
PubMed 23799962Kassem 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.
PubMed 33541354
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dental Anxiety in Patients Undergoing Different Dental Treatments - A Prospective Study
- ClinicalTrials.gov ID
- NCT06485973
- Acronym / sponsor ID
- DENANX / IAUDENT-01
- Conditions
- Dental Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Asst. Prof. Dr. Suleyman Emre MeseliUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 3 Jul 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | – | Other: Modified Dental Anxiety Scale (MDAS)Participants who are involved in the treatment planning of any of the following treatments: filling, root canal treatment, scaling, implant treatment and tooth extraction. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -To stop volunteering until the study is completed.
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 |
|---|---|---|
| Modified Dental Anxiety Scale (MDAS)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. | Other | All Participants |
Primary outcome
Modified Dental Anxiety Scale
Time frame: 1 hour
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.
3 secondary outcomes
Demographical Outcomes
Time frame: 1 hour
Oral and Dental Health Experiences and Attitudes
Time frame: 1 hour
Dental Anxiety Assessment
Time frame: 1hour
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 3 Jul 2024.
- Background: PubMed 27022303Appukuttan 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.
- Background: PubMed 23799962Humphris 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.
- Results publication: PubMed 33541354Kassem 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Asst. Prof. Dr. Suleyman Emre Meseli 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 5 inclusion and 1 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 3 Jul 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?
Modified Dental Anxiety Scale (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06485973, which also lists 3 linked publications.
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 3 Jul 2024.