Virtual Reality vs Nitrous Oxide for Pediatric Dentistry

Overseen By Lacey Williams, DMD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Geisinger Clinic

Disqualifiers: Seizures, ASA 3 or 4, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 visits

62 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is nitrous oxide safe for use in pediatric dentistry?

Nitrous oxide, commonly known as laughing gas, is generally considered safe when used as an anesthetic in medical settings like dentistry. However, excessive or recreational use can lead to side effects such as dizziness, memory issues, and vitamin B12 deficiency, which can cause nerve damage if not addressed. ^{1 2 3 4 5}

How does the treatment of Virtual Reality vs Nitrous Oxide for Pediatric Dentistry differ from other treatments?

This treatment is unique because it compares the use of virtual reality headsets, which provide a distraction therapy, with nitrous oxide (laughing gas), a common sedative, to manage anxiety and pain in children during dental procedures. Unlike traditional methods that rely solely on medication, this approach explores the potential of immersive technology to reduce discomfort and anxiety. ^{6 7 8 9 10}

What is the purpose of this trial?

Two groups of pediatric patients between the ages of 4 to 12 years old will be examined in this study. Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O. The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit where N2O will be used instead of VR. Procedures performed in all groups will be restorative treatments, which can include intraoral anesthetic injections, placing dental fillings, crowns, and the extractions of teeth. In group 1, A specific VR headset, the "Oculus Quest 2" will be used. Through the headset, a video will be played for the child during a dental procedure.

Eligibility Criteria

This trial is for kids aged 4-12 who need dental work like fillings or tooth removal and can handle anesthesia. They must be in good health overall (ASA class 1 or 2). Kids with serious health issues, a high risk of seizures from lights and sounds, or those too sick for VR (ASA class 3 or 4) can't join.

Inclusion Criteria

I need two procedures that will involve getting anesthesia shots.

I am a child between 4 and 12 years old needing dental care.

I am in good or mild systemic disease condition according to ASA.

Exclusion Criteria

I have a serious health condition that limits my activity but is not incapacitating.

Have health issues that prevent use of VR Oculus headset

Hypersensitivity to audio-visual devices that can lead to seizures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive dental treatment with either Nitrous Oxide or Virtual Reality goggles, followed by a second visit with the alternate method

2 visits

2 visits (in-person)

Follow-up

Participants are monitored for pain and discomfort using FLACC and Houpt scales

12 months

Treatment Details

Interventions

• Nitrous Oxide
• Virtual Reality Headset

Trial Overview The study tests if using a VR headset during dental treatment helps as much as laughing gas (N2O) to keep kids calm. Each child tries both methods at different visits. The Oculus Quest 2 will play videos during the procedures to distract them.

Participant Groups

Group I: Treatment: Virtual Reality Goggles, then Nitrous Oxide Experimental Treatment 2 Interventions

The treatment group will receive the standard of care dental treatment with VR googles first and will have a second visit under N2O will be used instead of VR.

Group II: Control: Nitrous Oxide, then Virtual Reality Goggles Experimental Treatment 2 Interventions

Control group will receive the standard of care dental treatment with under nitrous sedation (N2O) and will have a second visit where Virtual Reality(VR) goggles will be used instead of N2O.

Nitrous Oxide is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Nitrous oxide for:

• Anesthesia
• Pain relief
• Hypoxic respiratory failure in neonates

Approved in United States as Nitrous oxide for:

• Anesthesia
• Pain relief
• Hypoxic respiratory failure in neonates

Approved in Canada as Nitrous oxide for:

• Anesthesia
• Pain relief
• Hypoxic respiratory failure in neonates

Who Is Running the Clinical Trial?

Geisinger Clinic

Lead Sponsor

Trials

159

Recruited

1,976,000+

Findings from Research

A systematic review identified 59 cases of nitrous oxide (N2O) use disorder and 17 cases of EMONO use disorder, highlighting the potential for addiction, especially when used in larger quantities and for longer durations than intended.

The study suggests that N2O use disorder can develop not only from recreational use but also from medical exposure, indicating a need for careful monitoring of its use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nitrous oxide: What do we know about its use disorder potential? Results of the French Monitoring Centre for Addiction network survey and literature review. Fidalgo, M., Prud'homme, T., Allio, A., et al.[2020]

Nitrous oxide (N2O) is commonly used as an anesthetic and analgesic, but its recreational abuse, particularly among young adults, poses significant health risks, especially to the nervous system.

Long-term N2O abuse can lead to irreversible neurological damage, making it crucial to discontinue use and provide timely vitamin B12 supplementation for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recreational Nitrous Oxide Abuse: Prevalence, Neurotoxicity, and Treatment. Xiang, Y., Li, L., Ma, X., et al.[2021]

Nitrous oxide (N2O) is widely used as a safe anesthetic and has a rapid onset of euphoric effects when inhaled recreationally, particularly among clubbers and festival-goers, with usage rates between 40% and 80%.

While N2O is generally considered safe for moderate use, heavy or sustained use can lead to vitamin B12 deficiency and associated neurological issues, highlighting the need for user education about these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recreational nitrous oxide use: Prevalence and risks. van Amsterdam, J., Nabben, T., van den Brink, W.[2022]

A systematic review of 34 studies on recreational nitrous oxide (N2O) use highlights a concerning increase in its use and associated harms, particularly among young people, yet there is a lack of awareness about these risks.

The review calls for improved harm reduction strategies, emphasizing the need for both policy changes and service delivery improvements to better address the growing issue of N2O use and its potential dangers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Recreational Nitrous Oxide Use: Implications for Policy, Service Delivery and Individuals. Allan, J., Cameron, J., Bruno, J.[2023]

An 18-year-old female developed severe cognitive dysfunction and encephalatrophy after 5 months of recreational N2O use, suggesting that long-term exposure can lead to significant neurological issues.

Treatment with hyperbaric oxygen therapy (HBOT) over approximately 20 days resulted in a complete recovery of cognitive function, indicating that HBOT may be an effective intervention for N2O-related toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy to improve cognitive dysfunction and encephalatrophy induced by N2O for recreational use: a case report. Luo, D., Xu, J., Hu, L., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Nitrous oxide: What do we know about its use disorder potential? Results of the French Monitoring Centre for Addiction network survey and literature review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Recreational Nitrous Oxide Abuse: Prevalence, Neurotoxicity, and Treatment. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Recreational nitrous oxide use: Prevalence and risks. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of Recreational Nitrous Oxide Use: Implications for Policy, Service Delivery and Individuals. [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Hyperbaric oxygen therapy to improve cognitive dysfunction and encephalatrophy induced by N2O for recreational use: a case report. [2020]

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Comparison of endoflas and zinc oxide eugenol as root canal filling materials in primary dentition. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

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