Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2025-01-20
2025-11-20
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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classical music group
a music type used in the management of dental anxiety
classical music group
classical music therapy with standard restorative treatment
turkish music group
a music type used in the management of dental anxiety
turkish music group
Turkish music therapy with standard restorative treatment
control
no music therapy
control
no music therapy with standard restorative treatment
Interventions
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classical music group
classical music therapy with standard restorative treatment
turkish music group
Turkish music therapy with standard restorative treatment
control
no music therapy with standard restorative treatment
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
40 Years
ALL
Yes
Sponsors
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Ataturk University
OTHER
Responsible Party
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Neslihan Celik
Assoc. Prof.
Locations
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Ataturk university, Faculty of dentistry, Department of restorative Dentistry clinics
Erzurum, Erzurum, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TSA-2023-12101
Identifier Type: -
Identifier Source: org_study_id
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