Not Yet Recruiting AR Glasses and Noise Canceling Headphones for Adult Dental Anxiety: A Regulatory View

A not yet recruiting clinical study from the Medical University of Warsaw tests augmented reality glasses with video and music and noise cancelling headphones to ease dental anxiety in adults.

Publication date context: February 11, 2026. The trial targets adults undergoing dental procedures and uses AR glasses with video and music, ANC headphones with music, and sensory placebo devices. Sponsor is the Medical University of Warsaw. The record lists Not yet recruiting and references ClinicalTrials.gov NCT07398898.

What changed in addressing dental anxiety with wearables?

The study introduces devices to address anxiety during dental procedures. It uses Interventions: AR Glasses with Video and Music; ANC Headphones with Music; and Sensory Placebo Devices. The conditions include dental anxiety, music therapy, and oral surgical procedures. Sponsor is the Medical University of Warsaw. The record lists Not yet recruiting and references ClinicalTrials.gov NCT07398898.

What is the intended use?

The sponsor describes the devices as a combination to mitigate anxiety during dental procedures through distraction and auditory stimuli. This is the trial objective and not a claim of proven efficacy.

What is being tested and how is the trial designed?

The trial aims to evaluate whether AR glasses with video and music and ANC headphones with music can reduce dental anxiety in adults undergoing oral surgical procedures. The study is not yet recruiting and is sponsored by the Medical University of Warsaw. The clinical trial record on ClinicalTrials.gov lists NCT07398898.

What are the safety and regulatory considerations?

Under regulatory style, this trial describes an intended use for consumer devices used in a clinical context. The status Not yet recruiting implies pending regulatory clearance and ethical approvals. Statements about device safety and performance should come from the sponsor and must be verified by regulatory authorities. The sponsor should provide risk management documentation and conformity assessment per MDR Annex XIV for devices used in clinical trials. This article reports only the trial context as described in the ClinicalTrials.gov entry.

What is the timeline and current status?

The record shows Not yet recruiting as of the referenced date. No recruitment dates are provided in the source text. The next steps include regulatory approvals, ethics review, and start of recruitment if applicable. Readers should monitor the ClinicalTrials.gov entry for updates.

FAQ

  1. 1. What is being studied?

    The trial tests the use of AR glasses with video and music and noise cancelling headphones with music to address dental anxiety in adults during dental procedures.

  2. 2. Who sponsors this study?

    The sponsor is the Medical University of Warsaw.

  3. 3. Where can I find official trial information?

    Information is available on ClinicalTrials.gov under NCT07398898; use the provided link for details.

The study investigates a technology driven approach to reducing dental anxiety in adults using AR glasses and noise cancelling headphones. With not yet recruiting status, the trial aims to establish feasibility and user tolerance before broader regulatory submission. Stakeholders including clinicians, device manufacturers, and regulators may watch for future updates on device performance and safety data.

Disclaimer: This article is intended for professionals and is not legal advice. It summarizes the trial context from the source text and does not provide medical recommendations.

For full information about the announcement, see the link below.

https://clinicaltrials.gov/study/NCT07398898?term=medical+device

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