Pain Perception and Anxiety With Virtual Reality vs Tell-Show-Do in Children With MIH

NCT ID: NCT07052019

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-01

Brief Summary

This pilot crossover randomized clinical trial aims to compare the effect of distraction using Virtual Reality (VR) versus the Tell-Show-Do (TSD) technique on pain perception and anxiety in children aged 6-12 with Molar Incisor Hypomineralization (MIH) undergoing restorative dental treatment.

Detailed Description

Molar Incisor Hypomineralization is a prevalent developmental condition affecting the enamel of first permanent molars and, occasionally, incisors. It presents significant clinical challenges due to the hypersensitivity and increased pain perception in affected teeth, which can make restorative treatment especially distressing for pediatric patients. Children with MIH are often apprehensive toward dental procedures, resulting in higher levels of dental anxiety that can impact their cooperation and the overall success of treatment. The management of pain and anxiety during restorative treatments is therefore crucial, particularly in this vulnerable population.

Behavioral management techniques, such as the Tell-Show-Do (TSD) approach, have been widely used in pediatric dentistry to alleviate anxiety and improve patient cooperation. However, recent advances in digital technology, particularly Virtual Reality (VR), offer novel, immersive forms of distraction that could enhance pain management by shifting the child's attention away from the dental procedure. VR distraction has shown promise in reducing anxiety and pain perception across various medical and dental settings, but its efficacy compared to traditional behavioral techniques, such as TSD, remains under-explored, especially in the context of MIH.

A recent systematic reviews of behavioral interventions in pediatric dentistry highlighted a lack of robust evidence regarding the effectiveness of VR as a distraction technique in dental settings, particularly in randomized controlled trials (RCTs). The reviews specifically called for more rigorous studies to directly compare VR with established techniques like TSD in managing dental anxiety and pain perception. Given this identified gap in the literature, this study aims to address these limitations by conducting a crossover randomized clinical trial to compare VR distraction with TSD in children with MIH undergoing restorative treatment. By examining both pain perception and anxiety levels, this study seeks to contribute valuable insights into the comparative effectiveness of VR and TSD, providing evidence-based recommendations for pediatric dental practitioners.

Conditions

Molar Incisor Hypomineralization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: Virtual Reality then Tell-Show-Do

Children receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period).

Group Type: EXPERIMENTAL

Virtual Reality Distraction

Intervention Type: DEVICE

Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.

Tell-Show-Do Technique

Intervention Type: BEHAVIORAL

Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.

Arm B: Tell-Show-Do then Virtual Reality

Children receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period).

Group Type: ACTIVE_COMPARATOR

Virtual Reality Distraction

Intervention Type: DEVICE

Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.

Tell-Show-Do Technique

Intervention Type: BEHAVIORAL

Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.

Interventions

Virtual Reality Distraction

Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.

Intervention Type: DEVICE

Tell-Show-Do Technique

Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Children aged between 6-12 years.
• Patients with two First Permanent molars diagnosed with MIH indicated for class I cavities.
• A cooperative and compliant patient/ parent.
• Patients not allergic to medicaments necessary to complete the procedure.
• Patients with no history of chronic systemic diseases.

Exclusion Criteria

• MIH-affected molars require apexogenesis, apexification, regeneration or RCT.
• Non-restorable tooth.
• Previous restorative treatment.
• Periodontally affected.
• Children having systemic disease, an emotional behavioural or learning disorder.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hagar Saleem Mojahed Abou-Musallam

Lecturer Assistant at Pediatric Dentistry Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

faculty of dentistry, Cairo university

Giza, Giza Governorate, Egypt

Countries

Egypt

Facility Contacts

Hagar Saleem Hagar Saleem Mojahed Aboumusallam, Master degree

Role: primary

hagarsaleem@gmail.com

00201110646161

Other Identifiers

U Cairo Hagar

Identifier Type: -

Identifier Source: org_study_id