Dental AnxietyNCT07173491
Music Therapy in Restorative Dentistry
A study testing classical music group and turkish music group in people with Dental Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
After administering a questionnaire to collect demographic data (including gender, age, education level, and frequency of dental visits) and MDAS scores, patients with an MDAS score of 10 or higher, indicating moderate to high dental anxiety, will be randomly allocated into three groups (n = 25 per group). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- classical music group and turkish music group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy adults aged 18-40 years.
- Presence of D2 dentin caries confirmed by clinical and radiographic examination, characterized by radiolucency limited to the outer half of the dentin without pulpal or periapical pathology,
- Indication for single-session restorative treatment,
- Individuals with moderate-to-high dental anxiety according to the Modified Dental Anxiety Scale (MDAS), defined as a total score ≥10 (moderate: 10-18; high: ≥19).
- Ability and willingness to complete questionnaires and comply with study procedures.
Who cannot join
- deep dentin or pulpal involvement lesions, secondary caries, cracks, or fractured teeth,
- Acute or spontaneous dental pain, percussion sensitivity, or periapical pathology,
- Individuals with an MDAS total score ≤ 9 (no/low dental anxiety) were excluded.
- Hearing impairment or contraindications for music therapy,
- Psychiatric medication use or a diagnosed psychiatric disorder affecting anxiety response,
- Pregnant or breastfeeding individuals.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk university, Faculty of dentistry, Department of restorative Dentistry clinics
Erzurum, Erzurum, 25240
neslihan çelik, Phd, 05065640964, dtnesli@hotmail.com
Merve İŞcan Yapar, phd
About this study
Official title: Effectiveness of Music-Based Interventions in Reducing Dental Anxiety During Restorative Dental Treatment
After administering a questionnaire to collect demographic data (including gender, age, education level, and frequency of dental visits) and MDAS scores, patients with an MDAS score of 10 or higher, indicating moderate to high dental anxiety, will be randomly allocated into three groups (n = 25 per group). Standard restorative treatment will be performed on the selected patients under music therapy.
Read the detailed description
A single carpule of local anesthetic without vasoconstrictor will be administered to each patient using a disposable dental syringe. Following anesthesia, caries removal and cavity preparation will be performed. The restorative procedure will then commence. All procedures will be performed by the same clinician following a standardized protocol. Selective enamel etching will be performed with phosphoric acid for 30 seconds, followed by rinsing and gentle drying. Universal dental adhesive will be applied and polymerized according to the manufacturer's instructions. Subsequently, the prepared cavities will be restored with a resin composite, which will be light-cured for 20 seconds using an LED curing unit. Upon completion of finishing and polishing, the total duration of the restorative procedure will be recorded. Only one restoration will be performed for each patient.
Assessment of Physiological and Salivary Biomarkers In this study, systolic and diastolic blood pressure (SBP and DBP), oxygen saturation (SpO₂), heart rate (HR), salivary cortisol levels, salivary alpha-amylase (sAA) levels, and MDAS scores will be measured twice-once initially and once after the restorative procedure. Blood pressure will be recorded using a manual sphygmomanometer on the patients' right arms at heart level, and results will be expressed in mmHg. HR and SpO₂ will be measured with a finger-type portable pulse oximeter placed on the right index finger.
Unstimulated saliva samples will be collected from each participant just before and immediately after the procedure. Patients will be instructed to expectorate into sterile disposable tubes, ensuring the samples are free of blood contamination. To control for circadian fluctuations in cortisol and sAA levels, all samples will be collected between 9:00 and 12:00 a.m. The collected samples will be immediately stored at -80 °C until analysis.
A blinded researcher will perform all biochemical analyses after the completion of patient treatments. Samples will be thawed and centrifuged at 3,000 × g for 10 minutes. Cortisol concentrations will be determined using an enzyme-linked immunosorbent assay (ELISA) kit, while salivary alpha-amylase activity will be quantified with a colorimetric enzymatic assay. Absorbance values will be measured at a wavelength of 450 nm, and the results will be expressed in nanograms per milliliter (ng/ml) for cortisol and units for alpha-amylase.
- Conditions
- Dental Anxiety
- Being tested
- classical music group, turkish music group, control
- Keywords
- restorative treatment, dental anxiety, music therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
classical music groupOther
classical music therapy with standard restorative treatment
turkish music groupOther
Turkish music therapy with standard restorative treatment
controlOther
no music therapy with standard restorative treatment
| Study group | Role | What they receive |
|---|---|---|
| classical music group | Experimental | a music type used in the management of dental anxiety Receives: Other: classical music group |
| turkish music group | Experimental | a music type used in the management of dental anxiety Receives: Other: turkish music group |
| control | Placebo comparator | no music therapy Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure (SBP)
Systolic blood pressure will be measured in a seated position using an automated sphygmomanometer. (Unit of Measure: mmHg)
Measured: at baseline and immediately after the restorative treatment
Diastolic Blood Pressure (DBP)
Diastolic blood pressure will be measured in a seated position using an automated sphygmomanometer. (Unit of Measure: mmHg)
Measured: at baseline and immediately after the restorative treatment
Oxygen Saturation (SpO₂)
Peripheral oxygen saturation will be assessed non-invasively using a finger pulse oximeter.
Measured: at baseline and immediately after the restorative treatment
Heart Rate (HR)
Heart rate will be measured concurrently with blood pressure using an automated sphygmomanometer. (Unit of Measure: beats per minute (bpm))
Measured: at baseline and immediately after the restorative treatment
Salivary Cortisol Levels
Salivary cortisol concentrations will be analyzed using an ELISA kit according to the manufacturer's protocol. (Unit of Measure: ng/mL)
Measured: at baseline and immediately after the restorative treatment
Salivary Alpha-Amylase (sAA) Levels
Salivary alpha-amylase concentrations will be analyzed using an ELISA kit according to the manufacturer's protocol. (Unit of Measure: ng/mL)
Measured: At baseline and immediately after the restorative treatment
Modified Dental Anxiety Scale (MDAS) Score
Anxiety levels will be assessed using the validated Modified Dental Anxiety Scale questionnaire. A 5-item anxiety scale; each item is rated 1-5 (Likert). The total score ranges from 5 to 25. Higher scores indicate greater dental anxiety (worse outcome). The outcome will be reported as change from baseline (Δ).
Measured: at baseline and immediately after the restorative treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start20 Jan 2025
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
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 Ataturk 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups with a control group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neslihan Celik, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07173491
- Sponsor's protocol ID
- TSA-2023-12101
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 29 Sep 2025
- 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 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music-Based Interventions in Reducing Dental Anxiety During Restorative Dental Treatment
- ClinicalTrials.gov ID
- NCT07173491
- Acronym / sponsor ID
- TSA-2023-12101
- Conditions
- Dental Anxiety
- Keywords
- restorative treatment, dental anxiety, music therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 15 Sep 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.
After administering a questionnaire to collect demographic data (including gender, age, education level, and frequency of dental visits) and MDAS scores, patients with an MDAS score of 10 or higher, indicating moderate to high dental anxiety, will be randomly allocated into three groups (n = 25 per group). Standard restorative treatment will be performed on the selected patients under music therapy.
Detailed description
A single carpule of local anesthetic without vasoconstrictor will be administered to each patient using a disposable dental syringe. Following anesthesia, caries removal and cavity preparation will be performed. The restorative procedure will then commence. All procedures will be performed by the same clinician following a standardized protocol. Selective enamel etching will be performed with phosphoric acid for 30 seconds, followed by rinsing and gentle drying. Universal dental adhesive will be applied and polymerized according to the manufacturer's instructions. Subsequently, the prepared cavities will be restored with a resin composite, which will be light-cured for 20 seconds using an LED curing unit. Upon completion of finishing and polishing, the total duration of the restorative procedure will be recorded. Only one restoration will be performed for each patient.
Assessment of Physiological and Salivary Biomarkers In this study, systolic and diastolic blood pressure (SBP and DBP), oxygen saturation (SpO₂), heart rate (HR), salivary cortisol levels, salivary alpha-amylase (sAA) levels, and MDAS scores will be measured twice-once initially and once after the restorative procedure. Blood pressure will be recorded using a manual sphygmomanometer on the patients' right arms at heart level, and results will be expressed in mmHg. HR and SpO₂ will be measured with a finger-type portable pulse oximeter placed on the right index finger.
Unstimulated saliva samples will be collected from each participant just before and immediately after the procedure. Patients will be instructed to expectorate into sterile disposable tubes, ensuring the samples are free of blood contamination. To control for circadian fluctuations in cortisol and sAA levels, all samples will be collected between 9:00 and 12:00 a.m. The collected samples will be immediately stored at -80 °C until analysis.
A blinded researcher will perform all biochemical analyses after the completion of patient treatments. Samples will be thawed and centrifuged at 3,000 × g for 10 minutes. Cortisol concentrations will be determined using an enzyme-linked immunosorbent assay (ELISA) kit, while salivary alpha-amylase activity will be quantified with a colorimetric enzymatic assay. Absorbance values will be measured at a wavelength of 450 nm, and the results will be expressed in nanograms per milliliter (ng/ml) for cortisol and units for alpha-amylase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups with a control group
| Arm | Type | Receives |
|---|---|---|
| classical music group | Experimental | Other: classical music groupa music type used in the management of dental anxiety |
| turkish music group | Experimental | Other: turkish music groupa music type used in the management of dental anxiety |
| control | Placebo comparator | Other: controlno music therapy |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Systemically healthy adults aged 18-40 years.
- Presence of D2 dentin caries confirmed by clinical and radiographic examination, characterized by radiolucency limited to the outer half of the dentin without pulpal or periapical pathology,
- Indication for single-session restorative treatment,
- Individuals with moderate-to-high dental anxiety according to the Modified Dental Anxiety Scale (MDAS), defined as a total score ≥10 (moderate: 10-18; high: ≥19).
- Ability and willingness to complete questionnaires and comply with study procedures.
Key exclusion criteria (6 listed)
- deep dentin or pulpal involvement lesions, secondary caries, cracks, or fractured teeth,
- Acute or spontaneous dental pain, percussion sensitivity, or periapical pathology,
- Individuals with an MDAS total score ≤ 9 (no/low dental anxiety) were excluded.
- Hearing impairment or contraindications for music therapy,
- Psychiatric medication use or a diagnosed psychiatric disorder affecting anxiety response,
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 |
|---|---|---|
| classical music groupclassical music therapy with standard restorative treatment | Other | classical music group |
| turkish music groupTurkish music therapy with standard restorative treatment | Other | turkish music group |
| controlno music therapy with standard restorative treatment | Other | control |
Primary outcome
Systolic Blood Pressure (SBP)
Time frame: at baseline and immediately after the restorative treatment
Systolic blood pressure will be measured in a seated position using an automated sphygmomanometer. (Unit of Measure: mmHg)
Diastolic Blood Pressure (DBP)
Time frame: at baseline and immediately after the restorative treatment
Diastolic blood pressure will be measured in a seated position using an automated sphygmomanometer. (Unit of Measure: mmHg)
Oxygen Saturation (SpO₂)
Time frame: at baseline and immediately after the restorative treatment
Peripheral oxygen saturation will be assessed non-invasively using a finger pulse oximeter.
Heart Rate (HR)
Time frame: at baseline and immediately after the restorative treatment
Heart rate will be measured concurrently with blood pressure using an automated sphygmomanometer. (Unit of Measure: beats per minute (bpm))
Salivary Cortisol Levels
Time frame: at baseline and immediately after the restorative treatment
Salivary cortisol concentrations will be analyzed using an ELISA kit according to the manufacturer's protocol. (Unit of Measure: ng/mL)
Salivary Alpha-Amylase (sAA) Levels
Time frame: At baseline and immediately after the restorative treatment
Salivary alpha-amylase concentrations will be analyzed using an ELISA kit according to the manufacturer's protocol. (Unit of Measure: ng/mL)
Modified Dental Anxiety Scale (MDAS) Score
Time frame: at baseline and immediately after the restorative treatment
Anxiety levels will be assessed using the validated Modified Dental Anxiety Scale questionnaire. A 5-item anxiety scale; each item is rated 1-5 (Likert). The total score ranges from 5 to 25. Higher scores indicate greater dental anxiety (worse outcome). The outcome will be reported as change from baseline (Δ).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing classical music group and turkish music group in people with Dental Anxiety, run by Ataturk 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Sep 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neslihan Çelik, Phd (+905065640964, dtnesli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (SBP) (time frame: at baseline and immediately after the restorative treatment). The study lists 7 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 29 Sep 2025.