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NCT Number: NCT06998979

Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction

Music therapy is widely used in dentistry as it helps patients remain distracted during procedures, particularly during implant placement or third molar extraction. This therapy refers to the evidence-based clinical use of music to achieve therapeutic goals, administered by a licensed practitioner. Due to the high prevalence of complications associated with the eruption and development of wisdom teeth, there has been an increase in the rate of surgical extractions, which in turn elevates patients' dental anxiety. Music therapy may aid in the management of anxiety and thereby contribute to a reduction in pain perception. It is a favorable technique due to its low cost and minimal associated risks. In this context, and considering the widespread use of music as a therapeutic tool alongside the emergence of novel technologies-particularly Artificial Intelligence (AI)-this study aims to evaluate the efficacy of AI-generated music therapy in reducing dental anxiety during impacted third molar extraction procedures.

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Key information

Conditions

Tooth Extraction Anxiety Disorders Mental Disorders Molar, Third

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age who provided informed consent
  • Patients without severe or uncontrolled systemic diseases
  • Patients capable of completing the dental anxiety questionnaires

Exclusion criteria

  • Patients under 18 years of age
  • Patients with severe or uncontrolled systemic diseases
  • Patients using anxiolytic medications
  • Patients unable to complete the dental anxiety questionnaires

Treatment and study plan

Music Therapy

Behavioral

The music was generated using a beta version of the RIFFUSION program, which is still in its development phase and being refined based on user input. This software operates using neural networks similar to Generative Adversarial Networks (GANs), known as diffusion models. These models begin with random noise and gradually transform it into a musical composition through a process that involves two phases: a diffusion phase-where an existing musical sample is "disordered" by adding random noise-and a reverse phase, in which the noise is removed to reconstruct a new and distinct musical piece.

The prompt entered into the program was: "Relaxing slow music for people with great stress and extreme anxiety and panic caused by dental surgery with effects of wind and waterfall." A total of 20 songs were generated and merged to achieve a combined duration of 49.20 minutes.

Primary outcomes

  1. Corah's Dental Anxiety Scale

    Time frame: Baseline and immediately after surgery

    The Corah's Dental Anxiety Scale (CDAS) is a reliable instrument for assessing dental anxiety in adults. It consists of four questions addressing different dental situations. Each question is scored on a scale from 1 (not anxious) to 5 (extremely anxious), resulting in a total score ranging from 4 to 20. A score of 15 or higher indicates severe dental anxiety.

  2. Modified Dental Anxiety Scale

    Time frame: Baseline and immediately after surgery

    The Modified Dental Anxiety Scale (MDAS) is a concise, self-administered questionnaire designed to assess levels of dental anxiety. It comprises five items, each rated on a five-point Likert scale ranging from "not anxious" to "extremely anxious." The total score is obtained by summing the individual item scores, yielding a range from 5 to 25.

  3. Spielberger State-Trait Anxiety Inventory

    Time frame: Baseline and immediately after surgery

    The Spielberger State-Trait Anxiety Inventory is a widely recognized psychological instrument for assessing anxiety. It comprises 40 items divided into two subscales: state anxiety, which captures how an individual feels at a particular moment, and trait anxiety, which reflects general, long-term tendencies toward anxiety. Each item is rated on a four-point scale, with higher scores indicating greater levels of anxiety.

  4. Pain Intensity

    Time frame: Immediately after surgery

    To assess perceived pain during the procedure, the Visual Analog Scale (VAS) was used. This scale provides a subjective measure of pain intensity, ranging from 0 to 10, with higher values indicating greater pain.

Secondary outcomes

  1. Body temperature

    Time frame: Baseline and immediately after surgery

    Body temperature reflects the body's ability to regulate heat and maintain homeostasis. It will be measured using a digital thermometer placed axillary (underarm), The body temperature will be measurement in degrees Celsius (°C).

  2. Heart rate

    Time frame: Baseline and immediately after surgery

    Heart rate refers to the number of heartbeats per minute and serves as an indicator of cardiovascular function. It will be measured using a heart rate monitor. The unit of measurement is beats per minute (bpm).

  3. Blood pressure

    Time frame: Baseline and immediately after the surgery

    Blood pressure indicates the force exerted by circulating blood on the walls of the arteries. It will be measured using a digital sphygmomanometer placed around the upper arm. The unit of measurement is millimeters of mercury (mmHg), and it will be recorded as systolic over diastolic pressure (e.g., 120/80 mmHg).

  4. Oxygen saturation

    Time frame: Baseline and immediately after the surgery

    Oxygen saturation refers to the percentage of oxygen-saturated hemoglobin in the blood. It will be measured non-invasively using a pulse oximeter placed on the fingertip. The unit of measurement is percentage (%).

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • University of Salamanca

Registry information

Official study title

Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction: A Randomized Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 31, 2025
Registry last updated
May 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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