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

Not Applicable

Not yet recruiting

• Conditions: Molar Incisor Hypomineralization

• Registration Number: NCT07052019
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-18
• Study First Submitted QC: 2025-06-26
• Last Update Submitted: 2025-06-26
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04
• Study Start: 2025-08-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pain perception	Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)	Tool: Wong Baker Faces Pain Rating Scale Unit: Score 0-10

Secondary Outcome Measures

Name	Time	Method
Anxiety level	Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)	Tool: Modified Child Dental Anxiety Scale (MCDAS-f) Unit: Score 8-40
Heart Rate	Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)	Tool: Pulse Oximeter Unit: Beats per minute
Oxygen Saturation	Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)	Tool: Pulse Oximeter Unit: %

Trial Locations

Locations (1)

faculty of dentistry, Cairo university; 🇪🇬 Giza, Egypt