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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Virtual Reality then Tell-Show-Do | Experimental | Children receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period). |
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| Arm B: Tell-Show-Do then Virtual Reality | Active Comparator | Children receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Distraction | Device | Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain perception | Tool: Wong Baker Faces Pain Rating Scale Unit: Score 0-10 | Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety level | Tool: Modified Child Dental Anxiety Scale (MCDAS-f) Unit: Score 8-40 | Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure) |
| Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of dentistry, Cairo university | Giza | Giza Governorate | 12611 | Egypt |
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| ID | Term |
|---|---|
| D000094604 | Molar Hypomineralization |
| D001519 | Behavior |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000094603 | Dental Enamel Hypomineralization |
| D000094602 | Developmental Defects of Enamel |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
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| Tell-Show-Do Technique | Behavioral | Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation. |
|
Tool: Pulse Oximeter Unit: Beats per minute
| Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes) |
| Oxygen Saturation | Tool: Pulse Oximeter Unit: % | Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes) |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |