Assessing the Effect of Virtual Reality Gamification on Anxiety and Pain Management During Extraction of MIH-affected Lower First Permanent Molars in Pediatric Patients

NCT ID: NCT06964451

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-01

Brief Summary

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The aim of this study was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of lower first molars with MIH under local anaesthesia.

Detailed Description

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Dental anxiety can be tiggered by previous negative experiences, fear of pain, or loss of control, leading to avoidance of dental treatments and worsening oral health. To alleviate anxiety, various pharmacological and non-pharmacological measures are applied, including distraction as a cognitive-behavioral approach. One innovative method of distraction is gamification, which involves the use of Virtual Reality (VR) to redirect patients' focus to something relaxing instead of the treatment itself. The aim of this research was to evaluate the effectiveness of gamified virtual reality in reducing anxiety and pain during the extraction of molar-incisal hypomineralization (MIH) affected lower first molars under local anaesthesia. In prospective study, gamified virtual reality was applied during the extraction of lower first molars in 56 subjects using the split-mouth method. Through VR goggles, patients were immersed in a virtual video game world to distract them from the dental procedure.

Conditions

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Virtual Reality Distraction Gamification Tooth Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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NON VR

In the extraction of one tooth, the procedure was performed according to the standard protocol (Non VR Phase).

Group Type ACTIVE_COMPARATOR

Extraction tooth

Intervention Type PROCEDURE

Extraction of MIH Grade 4 molar

VR

For the tooth on the opposite side, the entire extraction procedure (including the application of local anesthesia) was conducted using a gamification model with VR goggles (VR Gamification Phase)

Group Type ACTIVE_COMPARATOR

Extraction tooth

Intervention Type PROCEDURE

Extraction of MIH Grade 4 molar

Interventions

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Extraction tooth

Extraction of MIH Grade 4 molar

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Indication for the extraction of both lower first molars due MIH grade 4.
Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rasa Mladenovic

OTHER

Sponsor Role lead

Responsible Party

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Rasa Mladenovic

Assistant professor, Pediatric dentist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Faculty od Medical Sciences University of Kragujevac

Kragujevac, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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Ethics Committee

Identifier Type: OTHER

Identifier Source: secondary_id

01-14788/2022

Identifier Type: -

Identifier Source: org_study_id

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