Dental AnxietyNCT06764758
Anxiety Levels of Patients Subjected to Endodontic and Restorative Treatment
A study testing Endodontic treatment and Restorative treatment in people with Dental Anxiety, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to compare the stress levels induced in patients at the beginning and at the end of endodontic and restorative treatments and access relationship between dental anxiety levels and cortisol levels. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Endodontic treatment and Restorative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2024to 4 Oct 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants over 18 years old
- Participants who are classified as ASA I according to the American Society of Anaesthesiologists (ASA) physical status classification system.
- Patients who require root canal treatment and will have composite restoration afterwards.
Who cannot join
- Patients with communication and cooperation problems.
- Patients who take medication regularly.
- Conditions such as Sjögren's syndrome or xerostomia, which affect salivary flow.
- Pregnancy.
- Patients with systemic diseases.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent University Faculty of Dentistry, Ankara, Turkey
Ankara, 06490
About this study
Official title: Short-Term Clinical Comparison of Anxiety Levels With Salivary Cortisol Levels in Patients Undergoing Endodontic and Restorative Treatment
This study aimed to compare the stress levels induced in patients at the beginning and at the end of endodontic and restorative treatments and access relationship between dental anxiety levels and cortisol levels.
For this study, 44 patients requiring endodontic and restorative treatment on a maxillary premolar tooth were selected. Patients were requested to fill out the Corah Dental Anxiety Scale (CDAS) questionnaire prior to and following each treatment procedure. Saliva samples were then collected using the roll cotton method. The saliva was analysed by using the Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) method. Intragroup comparisons of CDAS and cortisol levels were conducted using the Wilcoxon Signed Rank Test. Intergroup comparisons were performed employing the Mann-Whitney U Test. The magnitude of the association between continuous variables was investigated by calculating Spearman's rank-order correlation coefficients along with corresponding significance levels (p< 0.05).
Read the detailed description
Anxiety is a psychological state defined as significant worry, fear, and tension in response to perceived threats, dangers, or uncertainties. A key long-term consequence of stress exposure is an increased release of cortisol, a hormone regulated by the activation of the hypothalamic-pituitary-adrenal (HPA) axis and the adrenal glands. Cortisol is integral to the body's stress response, with its levels increasing notably during episodes of anxiety, thereby triggering physiological changes.
Dental anxiety, specifically, refers to an intense fear and apprehension associated with dental treatments. This type of anxiety may be associated with several factors, such as negative dental experience, the nature of dental procedures, or individual perception of treatment. Moreover, demographic factors like socioeconomic status, sex, education, and age can impact the development of dental anxiety. Also, childhood experiences of traumatic dental treatments are another critical factor, often resulting in negative attitudes toward dental care.
Research shows that dental anxiety tends to peak during procedures involving injections, though other treatments like dental restorations, endodontic treatment, and tooth extractions are also major sources of distress. Various approaches are utilized to assess dental anxiety, including measuring cortisol levels, administering self-report questionnaires, and using pain rating scales. Commonly applied tools include the Spielberger State-Trait Anxiety Inventory (STAI), Corah's Dental Anxiety Scale (CDAS), Dental Fear Survey (DFS), and the Modified Dental Anxiety Scale (MDAS).
The null hypothesis proposes that endodontic and restorative procedures evoke similar anxiety levels in patients, with no significant association detected between salivary cortisol levels and CDAS measurements.
- Conditions
- Dental Anxiety
- Being tested
- Endodontic treatment, Restorative treatment
- Keywords
- dental anxiety, salivary cortisol, dental anxiety scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic treatmentProcedure or surgery
Root-canal therapy applied in asymptomatic teeth with deep carious lesion required endodontic treatment.
Restorative treatmentProcedure or surgery
Composite resin restoration applied in teeth previously applied endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Endodontic treatment | Active comparator | gutta-percha (Sure Dent Corporation; Gyeonggi-do, Korea) Receives: Procedure: Endodontic treatment |
| Restorative treatment | Active comparator | Composite resin restorative material (3M Espe Filtek; Lake County, Minnesota, USA) Receives: Procedure: Restorative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corah's Dental Anxiety Scale
The general anxiety level associated with dental procedures was assessed through the Corah Dental Anxiety Scale (CDAS), which includes of four questions designed to evaluate the patient's dental anxiety level. The results were evaluated using a scoring system ranging from 4 (no anxiety) to 20 (high anxiety).
Measured: Day 1 and day 7
Secondary outcomes (1)
Salivary Cortisol Levels
In evaluating the patients' stress levels through experimental and chemical tests, the method of measuring cortisol levels from salivary samples was preferred. The results were evaluated using a scoring system ranging from 1.4 (low salivary cortisol level) -10.1(high salivary cortisol level) ng/ml.
Measured: Day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start27 Feb 2024
- Primary completion24 Sep 2024
- Study completion4 Oct 2024
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kamran Gulsahi, DDS., PhD, Study chair, Baskent University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764758
- Sponsor's protocol ID
- D-KA23/28
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data will be made available by contacting the first author
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-Term Clinical Comparison of Anxiety Levels With Salivary Cortisol Levels in Patients Undergoing Endodontic and Restorative Treatment
- ClinicalTrials.gov ID
- NCT06764758
- Acronym / sponsor ID
- D-KA23/28
- Conditions
- Dental Anxiety
- Keywords
- dental anxiety, salivary cortisol, dental anxiety scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 4 Oct 2024 (actual)
- First posted
- 8 Jan 2025 (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 aimed to compare the stress levels induced in patients at the beginning and at the end of endodontic and restorative treatments and access relationship between dental anxiety levels and cortisol levels.
For this study, 44 patients requiring endodontic and restorative treatment on a maxillary premolar tooth were selected. Patients were requested to fill out the Corah Dental Anxiety Scale (CDAS) questionnaire prior to and following each treatment procedure. Saliva samples were then collected using the roll cotton method. The saliva was analysed by using the Liquid Chromatography-Mass Spectrometry/Mass Spectrometry (LC-MS/MS) method. Intragroup comparisons of CDAS and cortisol levels were conducted using the Wilcoxon Signed Rank Test. Intergroup comparisons were performed employing the Mann-Whitney U Test. The magnitude of the association between continuous variables was investigated by calculating Spearman's rank-order correlation coefficients along with corresponding significance levels (p< 0.05).
Detailed description
Anxiety is a psychological state defined as significant worry, fear, and tension in response to perceived threats, dangers, or uncertainties. A key long-term consequence of stress exposure is an increased release of cortisol, a hormone regulated by the activation of the hypothalamic-pituitary-adrenal (HPA) axis and the adrenal glands. Cortisol is integral to the body's stress response, with its levels increasing notably during episodes of anxiety, thereby triggering physiological changes.
Dental anxiety, specifically, refers to an intense fear and apprehension associated with dental treatments. This type of anxiety may be associated with several factors, such as negative dental experience, the nature of dental procedures, or individual perception of treatment. Moreover, demographic factors like socioeconomic status, sex, education, and age can impact the development of dental anxiety. Also, childhood experiences of traumatic dental treatments are another critical factor, often resulting in negative attitudes toward dental care.
Research shows that dental anxiety tends to peak during procedures involving injections, though other treatments like dental restorations, endodontic treatment, and tooth extractions are also major sources of distress. Various approaches are utilized to assess dental anxiety, including measuring cortisol levels, administering self-report questionnaires, and using pain rating scales. Commonly applied tools include the Spielberger State-Trait Anxiety Inventory (STAI), Corah's Dental Anxiety Scale (CDAS), Dental Fear Survey (DFS), and the Modified Dental Anxiety Scale (MDAS).
The null hypothesis proposes that endodontic and restorative procedures evoke similar anxiety levels in patients, with no significant association detected between salivary cortisol levels and CDAS measurements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endodontic treatment | Active comparator | Procedure: Endodontic treatmentgutta-percha (Sure Dent Corporation; Gyeonggi-do, Korea) |
| Restorative treatment | Active comparator | Procedure: Restorative treatmentComposite resin restorative material (3M Espe Filtek; Lake County, Minnesota, USA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants over 18 years old
- Participants who are classified as ASA I according to the American Society of Anaesthesiologists (ASA) physical status classification system.
- Patients who require root canal treatment and will have composite restoration afterwards.
Key exclusion criteria (5 listed)
- Patients with communication and cooperation problems.
- Patients who take medication regularly.
- Conditions such as Sjögren's syndrome or xerostomia, which affect salivary flow.
- Pregnancy.
- Patients with systemic diseases.
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 |
|---|---|---|
| Endodontic treatmentRoot-canal therapy applied in asymptomatic teeth with deep carious lesion required endodontic treatment. | Procedure or surgery | Endodontic treatment |
| Restorative treatmentComposite resin restoration applied in teeth previously applied endodontic treatment. | Procedure or surgery | Restorative treatment |
Primary outcome
Corah's Dental Anxiety Scale
Time frame: Day 1 and day 7
The general anxiety level associated with dental procedures was assessed through the Corah Dental Anxiety Scale (CDAS), which includes of four questions designed to evaluate the patient's dental anxiety level. The results were evaluated using a scoring system ranging from 4 (no anxiety) to 20 (high anxiety).
1 secondary outcome
Salivary Cortisol Levels
Time frame: Day 1 and day 7
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 8 Jan 2025.
- Individual participant dataSharing planned: Yes. The de-identified data will be made available by contacting the first author
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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.
Kamran Gulsahi, DDS., PhD study chair
Baskent University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic treatment and Restorative treatment in people with Dental Anxiety, run by Baskent 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 3 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 8 Jan 2025. 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?
Corah's Dental Anxiety Scale (time frame: Day 1 and day 7). 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 8 Jan 2025.