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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) goggles or nitrous oxide (a relaxing gas) is more effective for children undergoing dental procedures. Participants will receive restorative dental treatments, such as fillings or extractions. One group will use nitrous oxide first, followed by VR, while the other group will do the reverse. The trial aims to determine which method provides more comfort during these procedures. Children aged 4 to 12 who require two dental treatments with anesthesia injections and are generally healthy may be suitable candidates. As an unphased trial, this study offers a unique opportunity for children to experience innovative comfort methods during dental care.

Will I have to stop taking my current medications?

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

What prior data suggests that these treatments are safe for pediatric dentistry?

Research has shown that both virtual reality (VR) and nitrous oxide safely manage anxiety and pain in children during dental treatments. Studies have found that VR effectively reduces pain and anxiety by providing a fun distraction during dental visits. Children often report feeling less pain and stress when using VR headsets.

Nitrous oxide, commonly known as "laughing gas," has also proven to safely help children relax during dental procedures. It reduces anxiety and pain, making the experience more comfortable. Parents generally express satisfaction with how nitrous oxide works for their children.

Both treatments have been well-tolerated, with no major side effects reported in the studies, indicating they are generally safe for use in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using virtual reality (VR) headsets in pediatric dentistry because they offer a unique way to manage anxiety and discomfort without medication. Unlike the traditional use of nitrous oxide, which can sometimes cause side effects like nausea or dizziness, VR provides a completely drug-free experience. The immersive nature of VR can effectively distract young patients, making dental visits less stressful and more enjoyable, potentially transforming the overall experience for kids. By offering an alternative to sedation, VR could also appeal to parents who prefer non-pharmacological options for their children.

What evidence suggests that this trial's treatments could be effective for pediatric dentistry?

This trial will compare the use of Virtual Reality (VR) headsets with Nitrous Oxide (N2O) for pediatric dental visits. Research has shown that VR headsets can reduce pain and anxiety for children during dental visits. Several studies have found that VR goggles make young patients feel less anxious and perceive less pain. In one study, researchers found that VR distraction lowered pain levels on a scale used to measure pain in children. Another study discovered that children using VR during dental treatments felt less fear and anxiety compared to those who didn't use VR. These findings suggest VR could be a useful tool to help kids feel more comfortable during dental visits. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9875280/

Distraction With Virtual Reality Goggles in Paediatric ... The results of this study corroborate reports of the effectiveness of the use of VR goggles in decreasing pain and anxiety levels during dental procedures ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05898100

Virtual Reality Distraction for Dental Anxiety (PILOT) A recent clinical trial by Alshatrat et al (2022) concluded that VR is an effective tool in reducing anxiety in young children during dental procedures.

3. frontiersin.org frontiersin.org/journals/oral-health/articles/10.3389/froh.2025.1539018/full

Effect of immersive virtual reality on pain in different dental ... Results confirmed that VR distraction significantly reduced pain perception, as measured by the FLACC scale, regardless of whether local ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0917239424000302

The effect of virtual reality glasses used in dental treatment ... According to some studies, children in intervention groups who use virtual reality during dental treatment have lower anxiety and fear levels compared to ...

5. jomos.org jomos.org/articles/mbcb/full_html/2024/02/mbcb240052/mbcb240052.html

Does immersive virtual reality reduce pain and anxiety in ... Our work confirms the very recent interest of immersive VR in reducing pain and anxiety in pediatric dentistry.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10711933/

Effectiveness of Nitrous Oxide Sedation on Child's Anxiety ... The administration of the N 2 O sedation results in a notable reduction in anxiety levels and pain perception, as well as better parental satisfaction.

7. aapd.org aapd.org/media/Policies_Guidelines/BP_UseofNitrous.pdf

Use of Nitrous Oxide for Pediatric Dental Patients Judicious use of N2O/O2 can provide a safe and effective method of controlling anxiety associated with dental treatment in children, adolescents, and persons ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265117/

Evaluation of dental treatments under nitrous oxide-oxygen ... Conclusion. Dental treatments under N2O-O2 inhalation sedation in pediatric dentistry are a safe method used for patients with dental anxiety.

9. cdc.gov cdc.gov/niosh/hhe/reports/pdfs/2005-0157-3110.pdf

Assessment of Nitrous Oxide Exposure in a Pediatric ... This Health Hazard Evaluation (HHE) report and any recommendations made herein are for the specific facility evaluated and may not be universally applicable ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024112546

Hypnosis and nitrous oxide impact on the school aged ... N 2 O/O 2 inhalation and hypnosis are effective in reducing self-reported and observed anxiety and improving cooperation levels in pediatric patients during ...