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NCT Number: NCT07052019

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

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Cairo university

Giza, Giza Governorate, 12611, Egypt

Location contact

Hagar Saleem Hagar Saleem Mojahed Aboumusallam, Master degree

CONTACT

[email protected]

00201110646161

hagar saleem Hagar Saleem Mojahed Aboumusallam, master degree

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual reality distraction

Device

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

Tell-Show-Do Technique

Behavioral

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

Primary outcomes

  1. Pain perception

    Time frame: 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 outcomes

  1. Anxiety level

    Time frame: 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

  2. Heart Rate

    Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)

    Tool: Pulse Oximeter Unit: Beats per minute

  3. Oxygen Saturation

    Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)

    Tool: Pulse Oximeter Unit: %

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Pain Perception and Anxiety With Virtual Reality Distraction Versus Tell-Show-Do Technique in Restorative Treatment for Children With Molar Incisor Hypomineralization: A Pilot Crossover Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 4, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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