Tooth ExtractionNCT06998979
Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction
A study testing Music therapy in people with Tooth Extraction and Molar, Third, run by University of Coimbra at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Extraction, Molar, Third
- What is being tested?
- Music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 4 Dec 2024to 20 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Maxillofacial Surgery at the University Hospital Complex of Salamanca
Salamanca, Salamanca, 37007
About this study
Official title: Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction: A Randomized Controlled Clinical Trial
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.
- Conditions
- Tooth Extraction, Molar, Third
- Being tested
- Music therapy
- Keywords
- Third molar extraction, Music therapy, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy | Active comparator | Patients in the experimental group listened to the music via ambient diffusion from a computer located in the surgical room throughout the entire procedure. Receives: Behavioral: Music therapy |
| Control | No intervention | In the control group, third molar extraction was performed without the application of any music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corah's Dental Anxiety Scale
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.
Measured: Baseline and immediately after surgery
Modified Dental Anxiety Scale
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.
Measured: Baseline and immediately after surgery
Spielberger State-Trait Anxiety Inventory
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.
Measured: Baseline and immediately after surgery
Pain Intensity
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.
Measured: Immediately after surgery
Secondary outcomes (4)
Body temperature
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).
Measured: Baseline and immediately after surgery
Heart rate
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).
Measured: Baseline and immediately after surgery
Blood pressure
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).
Measured: Baseline and immediately after the surgery
Oxygen saturation
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 (%).
Measured: Baseline and immediately after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start4 Dec 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Coimbra
- Sponsor type
- University, hospital or other
- Collaborators
- University of Salamanca
- Responsible party
- Principal investigator, Bruno Macedo de Sousa, University of Coimbra
- Investigators
- Jose Antonio B Rueda, PhD, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998979
- Sponsor's protocol ID
- USUCMUSIC2025
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artificial Intelligence-Generated Music Therapy in Reducing Dental Anxiety Among Adults Undergoing Impacted Third Molar Extraction: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06998979
- Acronym / sponsor ID
- USUCMUSIC2025
- Conditions
- Tooth Extraction, Molar, Third
- Keywords
- Third molar extraction, Music therapy, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CoimbraUniversity, hospital or other
- Collaborators
- University of Salamanca
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 31 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy | Active comparator | Behavioral: Music therapyPatients in the experimental group listened to the music via ambient diffusion from a computer located in the surgical room throughout the entire procedure. |
| Control | No intervention | –In the control group, third molar extraction was performed without the application of any music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Music therapyThe 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. | Behavioural | Music therapy |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Body temperature
Time frame: Baseline and immediately after surgery
Heart rate
Time frame: Baseline and immediately after surgery
Blood pressure
Time frame: Baseline and immediately after the surgery
Oxygen saturation
Time frame: Baseline and immediately after the surgery
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 31 May 2025.
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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.
Jose Antonio B Rueda, PhD principal investigator
University of Salamanca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Tooth Extraction and Molar, Third, run by University of Coimbra at 1 site in Spain.
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 4 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 31 May 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 Spain. 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: Baseline and immediately after surgery). The study lists 4 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 31 May 2025.