Molar Incisor HypomineralizationNCT07052019
Pain Perception and Anxiety With Virtual Reality vs Tell-Show-Do in Children With MIH
A study testing Virtual Reality Distraction and Tell-Show-Do Technique in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Molar Incisor Hypomineralization
- What is being tested?
- Virtual Reality Distraction and Tell-Show-Do Technique
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
faculty of dentistry, Cairo university
Giza, Giza Governorate, 12611
Hagar Saleem Hagar Saleem Mojahed Aboumusallam, Master degree, 00201110646161, hagarsaleem@gmail.com
hagar saleem Hagar Saleem Mojahed Aboumusallam, master degree
About this study
Official 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
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.
Read the 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
- Being tested
- Virtual Reality Distraction, Tell-Show-Do Technique
- Keywords
- Molar Incisor hypomineralization, MIH, virtual reality, behavioral, pain, anxiety
- Medical subject headings
- Molar Hypomineralization, Behavior, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DistractionDevice
Children wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety.
Tell-Show-Do TechniqueBehavioural
Conventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Virtual Reality Distraction; Behavioral: Tell-Show-Do Technique |
| 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). Receives: Device: Virtual Reality Distraction; Behavioral: Tell-Show-Do Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Tool: Wong Baker Faces Pain Rating Scale Unit: Score 0-10
Measured: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)
Secondary outcomes (3)
Anxiety level
Tool: Modified Child Dental Anxiety Scale (MCDAS-f) Unit: Score 8-40
Measured: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)
Heart Rate
Tool: Pulse Oximeter Unit: Beats per minute
Measured: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
Oxygen Saturation
Tool: Pulse Oximeter Unit: %
Measured: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralizationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Saleem Mojahed Abou-Musallam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052019
- Sponsor's protocol ID
- U Cairo Hagar
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07052019
- Acronym / sponsor ID
- U Cairo Hagar
- Conditions
- Molar Incisor Hypomineralization
- Keywords
- Molar Incisor hypomineralization, MIH, virtual reality, behavioral, pain, anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Virtual Reality then Tell-Show-Do | Experimental | Device: Virtual Reality Distraction, Behavioral: Tell-Show-Do TechniqueChildren receive restorative treatment with Virtual Reality distraction during the first session, and Tell-Show-Do technique during the second session (after washout period). |
| Arm B: Tell-Show-Do then Virtual Reality | Active comparator | Device: Virtual Reality Distraction, Behavioral: Tell-Show-Do TechniqueChildren receive restorative treatment with Tell-Show-Do technique in the first session, and Virtual Reality distraction in the second session (after washout period). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DistractionChildren wear virtual reality glasses during restorative dental treatment to reduce pain and anxiety. | Device | Arm A: Virtual Reality then Tell-Show-Do, Arm B: Tell-Show-Do then Virtual Reality |
| Tell-Show-Do TechniqueConventional behavioral technique where the dentist tells, shows, and then performs the procedure to reduce anxiety and build cooperation. | Behavioural | Arm A: Virtual Reality then Tell-Show-Do, Arm B: Tell-Show-Do then Virtual Reality |
Primary outcome
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
3 secondary outcomes
Anxiety level
Time frame: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)
Heart Rate
Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
Oxygen Saturation
Time frame: Baseline (5 minutes before session), during treatment (real-time), and immediately post-treatment (within 5 minutes)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Distraction and Tell-Show-Do Technique in people with Molar Incisor Hypomineralization, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain perception (time frame: Immediately before treatment (baseline), during treatment (within session), and immediately after treatment (post-procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.