NCT07273968

Brief Summary

Dental anxiety is common during third molar extractions and may exacerbate pain perception. Local anesthesia does not prevent exposure to stress-inducing stimuli. Virtual reality (VR) combined with hypnotic scripts (HypnoVR®) provides immersive multisensory distraction. This study tests whether VR reduces perioperative anxiety and postoperative pain compared to local anesthesia alone.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
16mo left

Started Mar 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress12%
Mar 2026Sep 2027

First Submitted

Initial submission to the registry

November 25, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 10, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

December 10, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 25, 2025

Last Update Submit

December 8, 2025

Conditions

Dental AnxietyThird Molar ExtractionOral Surgery

Outcome Measures

Primary Outcomes (2)

  • Anxiety reduction (MDAS questionnaire)

    5-item validated scale, score range 5-25

    Day 1

  • Anxiety reduction (MDAS questionnaire)

    5-item validated scale, score range 5-25

    Month1

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Wisdom tooth extraction under local anesthesia with immersive VR hypnosis (HypnoVR® system).

Device: Virtual reality HypnoVR® (VR headset + hypnotic software)

Control Group (No VR)

ACTIVE COMPARATOR

Wisdom tooth extraction under local anesthesia alone (no VR).

Other: Control Group (No VR)

Interventions

Virtual reality HypnoVR® (VR headset + hypnotic software)DEVICE

CE-marked class I device combining VR immersion with hypnotic text and music therapy to reduce anxiety and pain during oral surgery.

Virtual Reality Group
Control Group (No VR)OTHER

local anesthesia alone (no VR)

Control Group (No VR)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-65
  • Indication for extraction of 4 wisdom teeth or ≥2 mandibular wisdom teeth
  • ASA I-II
  • Written informed consent.

You may not qualify if:

  • Visual/hearing impairment
  • Psychiatric disorders or psychotropics (\<8 weeks)
  • Claustrophobia
  • Heavy smoking \>10 cig/day
  • Previous radiotherapy (jaw)
  • ASA III-IV
  • Pregnancy
  • Antithrombotic therapy
  • Chemotherapy
  • Bisphosphonates
  • Uncontrolled diabetes
  • Severe anxiety requiring GA or pharmacological sedation
  • No health insurance affiliation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 10, 2025

Study Start

March 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

December 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share