Music Therapy in Restorative Dentistry

NCT07173491 | Recruiting

• 1 other identifier: TSA-2023-12101
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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). Standard restorative treatment will be performed on the selected patients under music therapy.

Conditions

Dental Anxiety

Keywords

restorative treatment; dental anxiety; music therapy

Outcome Measures

Primary Outcomes (7)

• Systolic Blood Pressure (SBP)

  Systolic blood pressure will be measured in a seated position using an automated sphygmomanometer. (Unit of Measure: mmHg)

  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)

  at baseline and immediately after the restorative treatment

• Oxygen Saturation (SpO₂)

  Peripheral oxygen saturation will be assessed non-invasively using a finger pulse oximeter.

  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))

  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)

  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)

  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).

  at baseline and immediately after the restorative treatment

Study Arms (3)

classical music group

EXPERIMENTAL

a music type used in the management of dental anxiety

Other: classical music group

turkish music group

EXPERIMENTAL

a music type used in the management of dental anxiety

Other: turkish music group

control

PLACEBO COMPARATOR

no music therapy

Other: control

Interventions

classical music group OTHER

classical music therapy with standard restorative treatment

classical music group

turkish music group OTHER

Turkish music therapy with standard restorative treatment

turkish music group

control OTHER

no music therapy with standard restorative treatment

control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk university, Faculty of dentistry, Department of restorative Dentistry clinics

Erzurum, Erzurum, 25240, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Neslihan Çelik, Phd

CONTACT

+905065640964; dtnesli@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Model Details: three groups with a control group

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 15, 2025
• Study Start: January 20, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)